Diabetes Mellitus, Type 2Phase 3AWARD-1NCT01064687

A Study in Participants With Type 2 Diabetes Mellitus

A Phase 3 study testing LY2189265, Exenatide and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 89 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2189265, Exenatide and Metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 978 participants
Where: 89 sitesin 4 countries
Study dates: Feb 2010to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
Willing to inject subcutaneous (SC) medication up to 2 times per day
Stable weight for 3 months prior to screening
Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2)
Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.

Who cannot join

Type 1 Diabetes
HbA1c equal to or less than 6.5 before randomization or at randomization
Chronic insulin use
Taking drugs to promote weight loss by prescription or over the counter
Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
History of fluid retention or edema

Show all 20Show fewer

History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
Acute or chronic pancreatitis of any form
Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)
History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening
Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
Organ transplant except cornea
Have enrolled in another clinical trial within the last 30 days
Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study
Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Trial locations and contacts

89 sites in 4 countries.

Country

City, postcode or hospital

89 sites in 4 countries

United States78 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albany, New York, 12206
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Arlington, Texas, 76014
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30308
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Austin, Texas, 78731
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Bangor, Maine, 04401
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Beaver, Pennsylvania, 15009
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Bend, Oregon, 97701
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Biddeford, Maine, 04005
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Bloomfield Hills, Michigan, 48302
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Boise, Idaho, 83702
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Cary, North Carolina, 27518
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Cathedral City, California, 92234
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Charleston, South Carolina, 29412
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Cincinnati, Ohio, 45242
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Cleveland, Ohio, 44122
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Columbus, Ohio, 43210
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Concord, California, 94520
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Corpus Christi, Texas, 78404
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Corvallis, Oregon, 97330
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Crystal Lake, Illinois, 60012
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Dallas, Texas, 75231
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Danville, Pennsylvania, 17822
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Dayton, Ohio, 45439
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Delaware, Ohio, 43015
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Durham, North Carolina, 27713
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El Paso, Texas, 79925
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Elkridge, Maryland, 21075
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Eugene, Oregon, 97401
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Flint, Michigan, 48503
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Flushing, New York, 11365
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Fort Lauderdale, Florida, 33316
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Fresno, California, 93720
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Goodyear, Arizona, 85395
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Greenbrae, California, 94904
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Greenville, South Carolina, 29605
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Greer, South Carolina, 29651
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96813
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Idaho Falls, Idaho, 83404
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Lancaster, California, 93534
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Levittown, Pennsylvania, 19056
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Madisonville, Kentucky, 42431
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Memphis, Tennessee, 38119
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Meridian, Idaho, 83646
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Mission Hills, California, 91345
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Monterey, California, 93940
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Morehead City, North Carolina, 28557
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Myrtle Beach, South Carolina, 29572
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Nashua, New Hampshire, 03063
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National City, California, 91950
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New Britain, Connecticut, 06050
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New Orleans, Louisiana, 70112
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Oceanside, California, 92056
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Ogden, Utah, 84403
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Orlando, Florida, 32806
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Paramount, California, 90723
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Pembroke Pines, Florida, 33027
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Peoria, Illinois, 61615
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Perrysburg, Ohio, 43551
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85028
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Roseville, California, 95661
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San Antonio, Texas, 78258
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San Ramon, California, 94583
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Schertz, Texas, 78154
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Spokane, Washington, 99202
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St Louis, Missouri, 63141
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St. George, Utah, 84790
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Toms River, New Jersey, 08753
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Topeka, Kansas, 66606
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Tustin, California, 92780
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Vincennes, Indiana, 47591
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West Jordan, Utah, 84088
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West Palm Beach, Florida, 33401
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Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

Puerto Rico7 sites

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Caguas, 00726
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Hato Rey, 00917
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Manati, 00674
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Ponce, 00716
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San German, 00683
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San Juan, 00907
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Yabucoa, 00767

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Mexico3 sites

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Guadalajara, 44600
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Mexico City, 6700
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Monterrey, 64461

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Argentina1 site

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Buenos Aires, CBA 1419

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About this study

Official title: A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)

Read the detailed description

During the study, if a participant developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, the participant received additional therapeutic intervention or initiation of an alternative antihyperglycemic medication following study drug discontinuation (rescue therapy). Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified analyses.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2189265, Exenatide, Placebo, Metformin, Pioglitazone
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2189265Drug
Also called Dulaglutide
ExenatideDrug
PlaceboDrug
MetforminDrug
PioglitazoneDrug

Study groups in NCT01064687
Study group	Role	What they receive
1.5 mg LY2189265	Experimental	LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks Receives: Drug: LY2189265; Drug: Metformin; Drug: Pioglitazone
0.75 mg LY2189265	Experimental	LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks Receives: Drug: LY2189265; Drug: Metformin; Drug: Pioglitazone
Exenatide	Active comparator	Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks Receives: Drug: Exenatide; Drug: Metformin; Drug: Pioglitazone
Placebo	Placebo comparator	Placebo: subcutaneous (SC), once weekly for 26 weeks LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52). Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks Receives: Drug: LY2189265; Drug: Placebo; Drug: Metformin; Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 26 weeks

Secondary outcomes (46)

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks for Body Weight
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks for Body Weight
Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Body Mass Index (BMI)
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Measured: Baseline, 26 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the EuroQol 5
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version
The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions
The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change in Baseline to 26 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change in Baseline to 52 Weeks on Pulse Rate
Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52 weeks
Number of Participants With Adjudicated Pancreatitis at 26 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 weeks
Number of Participants With Adjudicated Pancreatitis at 52 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Change From Baseline to 26 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Serum Calcitonin
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Serum Calcitonin
Measured: Baseline, 52 weeks
Number of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 weeks
Number of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Rate of Self-reported Hypoglycemic Events at 26 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 weeks
Rate of Self-reported Hypoglycemic Events at 52 Weeks
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Measured: Baseline through 26 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia ("rescue therapy") was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate.
Measured: Baseline through 52 weeks
Number of Participants With LY2189265 Antibodies at 26 Weeks
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.
Measured: Baseline through 26 weeks
Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.
Measured: 26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose
Number of Participants With Treatment Emergent Adverse Events at 26 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 weeks
Number of Participants With Treatment Emergent Adverse Events at 52 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 52 weeks
Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values
Measured: Baseline, 26 weeks
Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values
Measured: Baseline, 52 weeks
Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
Measured: Baseline, 26 weeks
Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265
Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Measured: 4 weeks, 13 weeks, 26 weeks, and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010May 2012

First posted8 Feb 2010 (estimated)
Study startFeb 2010
Primary completionNov 2011
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 978 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064687
Sponsor's protocol ID: 11373
Other IDs: H9X-MC-GBDA
Acronym: AWARD-1
Status last verified: Jan 2015
First submitted: 5 Feb 2010
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
PubMed 36894938
Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
PubMed 27161178
Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
PubMed 26691396

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
ClinicalTrials.gov ID: NCT01064687
Acronym / sponsor ID: AWARD-1 / 11373
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 978 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Nov 2011 (actual)
Study completion: May 2012 (actual)
First posted: 8 Feb 2010 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1.5 mg LY2189265	Experimental	Drug: LY2189265, Drug: Metformin, Drug: PioglitazoneLY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
0.75 mg LY2189265	Experimental	Drug: LY2189265, Drug: Metformin, Drug: PioglitazoneLY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Exenatide	Active comparator	Drug: Exenatide, Drug: Metformin, Drug: PioglitazoneExenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Placebo	Placebo comparator	Drug: LY2189265, Drug: Placebo, Drug: Metformin, Drug: PioglitazonePlacebo: subcutaneous (SC), once weekly for 26 weeks LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52). Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
Willing to inject subcutaneous (SC) medication up to 2 times per day
Stable weight for 3 months prior to screening
Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2)

Key exclusion criteria (20 listed)

Type 1 Diabetes
HbA1c equal to or less than 6.5 before randomization or at randomization
Chronic insulin use
Taking drugs to promote weight loss by prescription or over the counter
Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2189265Also: Dulaglutide	Drug	0.75 mg LY2189265, 1.5 mg LY2189265, Placebo
Exenatide	Drug	Exenatide
Placebo	Drug	Placebo
Metformin	Drug	0.75 mg LY2189265, 1.5 mg LY2189265, Exenatide, Placebo
Pioglitazone	Drug	0.75 mg LY2189265, 1.5 mg LY2189265, Exenatide, Placebo

Primary outcome

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 26 weeks
Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.

46 secondary outcomes

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks for Body Weight
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks for Body Weight
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Body Mass Index (BMI)
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Body Mass Index (BMI)
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Time frame: Baseline, 52 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks
Time frame: Baseline, 26 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the EuroQol 5
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the EuroQol 5
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception
Time frame: Baseline, 52 weeks
Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks
Time frame: Baseline through 52 weeks
Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Time frame: Baseline, 52 weeks
Change in Baseline to 26 Weeks on Pulse Rate
Time frame: Baseline, 26 weeks
Change in Baseline to 52 Weeks on Pulse Rate
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Blood Pressure
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Blood Pressure
Time frame: Baseline, 52 weeks
Number of Participants With Adjudicated Pancreatitis at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Participants With Adjudicated Pancreatitis at 52 Weeks
Time frame: Baseline through 52 weeks
Change From Baseline to 26 Weeks on Pancreatic Enzymes
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Pancreatic Enzymes
Time frame: Baseline, 52 weeks
Change From Baseline to 26 Weeks on Serum Calcitonin
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks on Serum Calcitonin
Time frame: Baseline, 52 weeks
Number of Self-reported Hypoglycemic Events at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Self-reported Hypoglycemic Events at 52 Weeks
Time frame: Baseline through 52 weeks
Rate of Self-reported Hypoglycemic Events at 26 Weeks
Time frame: Baseline through 26 weeks
Rate of Self-reported Hypoglycemic Events at 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants With LY2189265 Antibodies at 26 Weeks
Time frame: Baseline through 26 weeks
Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug
Time frame: 26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1.5 mg LY2189265	279	245
0.75 mg LY2189265	280	254
Exenatide	278	237
Placebo	141	124

Primary outcome: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline, 26 weeks. Least squares mean (Standard Error). Unit: percentage of glycosylated hemoglobin

Measure	1.5 mg LY2189265 n = 271	0.75 mg LY2189265 n = 269	Exenatide n = 266	Placebo n = 119
Value	-1.51 (0.06)	-1.30 (0.06)	-0.99 (0.06)	-0.46 (0.08)

1.5 mg LY2189265 vs Placebo: LS Mean Difference: -1.05 (95% CI -1.22 to -0.88), p <0.001, ANCOVA
1.5 mg LY2189265 vs Exenatide: LS Mean Difference: -0.52 (95% CI -0.66 to -0.39), p <0.0001, ANCOVA
0.75 mg LY2189265 vs Placebo: LS Mean Difference: -0.84 (95% CI -1.01 to -0.67), p <0.001, ANCOVA

Population analysed: Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

46 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.75 mg LY2189265 (Baseline Through 26 Weeks)	15 of 280 (5.4%)	194 of 280 (69.3%)	Not reported
1.5 mg LY2189265 (Baseline Through 26 Weeks)	12 of 279 (4.3%)	215 of 279 (77.1%)	Not reported
Exenatide (Baseline Through 26 Weeks)	15 of 278 (5.4%)	196 of 278 (70.5%)	Not reported
Placebo (Baseline Through 26 Weeks)	12 of 141 (8.5%)	103 of 141 (73%)	Not reported
0.75 mg LY2189265 (Baseline Through 56 Weeks)	22 of 280 (7.9%)	218 of 280 (77.9%)	Not reported
1.5 mg LY2189265 (Baseline Through 56 Weeks)	18 of 279 (6.5%)	228 of 279 (81.7%)	Not reported
Exenatide (Baseline Through 56 Weeks)	27 of 278 (9.7%)	223 of 278 (80.2%)	Not reported
Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)	6 of 62 (9.7%)	47 of 62 (75.8%)	Not reported
Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)	9 of 62 (14.5%)	55 of 62 (88.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36894938Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
Derived from this study: PubMed 27161178Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
Derived from this study: PubMed 26691396Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

89 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY2189265, Exenatide and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 89 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Puerto Rico, Mexico, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064687, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.