Diabetes Mellitus, Type 2Phase 3NCT01191268
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
A Phase 3 study testing Insulin Glargine, LY2189265 and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 101 sites in 16 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin. 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?
- Insulin Glargine, LY2189265 and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- 101 sitesin 16 countries
- Study dates
- Nov 2010to Sep 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
- Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
- Willing to inject subcutaneous medication
- Willing to monitor blood glucose levels and adjust insulin dose
- Willing to maintain a study diary
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- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
- Stable weight for 3 months prior to screening
- Females of child bearing potential must test negative for pregnancy at screening 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
- Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
- 1 or more episodes of ketoacidosis within 6 months prior to screening
- Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
- Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
- Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
Show all 17Show fewer
- History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
- Acute or chronic hepatitis or pancreatitis
- Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
- Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
- Organ transplant except cornea
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
- Known drug or alcohol abuse
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 study
Trial locations and contacts
101 sites in 16 countries.
101 sites in 16 countries
United States36 sites
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Albany, New York, 12206
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Asheville, North Carolina, 28803
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Austin, Texas, 78731
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Chesterfield, Missouri, 63017
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Concord, California, 94520
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Dallas, Texas, 75230
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Eugene, Oregon, 97401
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Fargo, North Dakota, 58103
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Federal Way, Washington, 98003
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Haverhill, Massachusetts, 01830
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96813
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Indianapolis, Indiana, 46202
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Jacksonville, Florida, 32209
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La Mesa, California, 91942
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Lancaster, California, 93534
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Lexington, Kentucky, 40503
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Memphis, Tennessee, 38119
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Metairie, Louisiana, 70006
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Minneapolis, Minnesota, 55416
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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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New Britain, Connecticut, 06050
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New Orleans, Louisiana, 70121
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Paducah, Kentucky, 42003
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Renton, Washington, 98057
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Springfield, Massachusetts, 01199
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Toms River, New Jersey, 08753
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Topeka, Kansas, 66606
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Vancouver, Washington, 98664
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Waltham, Massachusetts, 02453
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401
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Winter Haven, Florida, 33880
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Worcester, Massachusetts, 01605
Hungary7 sites
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Békéscsaba, 5600
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Budapest, 1115
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Gyöngyös, 3200
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Miskolc, 3529
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Nagykanizsa, 8800
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Nyíregyháza, 4400
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Pápa, 8500
Spain6 sites
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Barcelona, 08022
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Madrid, 28046
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Palma de Mallorca, 07010
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Pozuelo de Alarcón, 28223
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Teruel, 44002
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Valencia, 46014
Canada5 sites
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Gatineau, Quebec, J8V 2P5
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London, Ontario, N6G 4X8
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New Westminster, British Columbia, V3L 3W5
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Sherbrooke, Quebec, J1G 5K2
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Winnipeg, Manitoba, R3E 3P4
Denmark5 sites
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Aarhus, 8000
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Copenhagen, 2400
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Hillerød, Dk-3400
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Koege, 4600
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Kolding, 6000
Taiwan5 sites
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Kaohsiung City, 807
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Sindian City, 23148
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Taichung, 404
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Taipei, 11031
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Yongkang District, 710
Argentina4 sites
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Buenos Aires, C1034ACO
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Cipolletti, 8324
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Mendoza, M5500CCE
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Salta, 4406
Belgium4 sites
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Bonheiden, 2820
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Brussels, 1070
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Genk, 3600
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Liège, 4000
Brazil4 sites
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Belém, 66073-000
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Fortaleza, 60430-350
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Porto Alegre, 90035-170
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São Paulo, 04266-010
Greece4 sites
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Ampelokipoi, 11527
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Athens, 11527
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Nikaias - Piraeus, 18454
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Thessaloniki, 54639
Mexico4 sites
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Culiacán, 80020
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Guadalajara, 44650
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Mérida, 97070
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Monterrey, 64461
Poland4 sites
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Gdynia, 81-557
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Lodz, 90-242
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Radzymin, 05-250
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Wroclaw, 50-349
Puerto Rico4 sites
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Manati, 00674
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Ponce, 00728
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San Juan, 00917-3104
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Yabucoa, 00767
Australia3 sites
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Box Hill, Victoria, 3128
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Keswick, South Australia, 5035
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Melbourne, Victoria, 3004
Russia3 sites
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Moscow, 127486
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Saint Petersburg, 191126
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Samara, 443095
Sweden3 sites
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Karlstad, 65185
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Lund, 22185
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.
Stockholm, 113 61
About this study
Official title: The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
Read the detailed description
The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, LY2189265, Insulin Lispro
- 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.
Insulin GlargineDrug
LY2189265Drug
Also called Dulaglutide
Insulin LisproDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.5 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks Receives: Drug: LY2189265; Drug: Insulin Lispro |
| 0.75 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks Receives: Drug: LY2189265; Drug: Insulin Lispro |
| Insulin Glargine | Active comparator | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks Receives: Drug: Insulin Glargine; Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
Measured: Baseline, 26 weeks
Secondary outcomes (29)
Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
Measured: Baseline, 52 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.
Measured: 26 weeks and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia
The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
The self-monitored plasma glucose (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 meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose
Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)
Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.
Measured: Baseline and 26 weeks and 52 weeks
Change From Baseline to 26 and 52 Weeks in Body Weight
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Measured: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the EQ-5D
The 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 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) adjusted by treatment, country, metformin use, and baseline.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) 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, treatment, and metformin use as fixed effects and baseline score as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)
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, treatment, and metformin use as fixed effects and baseline score as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)
The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.
Measured: Baseline, 26 weeks, and 52 weeks
Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).
Measured: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
Measured: Baseline, 26 weeks, and 52 weeks
Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Measured: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in 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, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.
Measured: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in 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, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate
Measured: Baseline, 26 weeks, and 52 weeks
Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Seated pulse rate was measured.
Measured: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in 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, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
Electrocardiogram (ECG) heart 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, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.
Measured: Baseline, 26 weeks, and 52 weeks
Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized 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 With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. 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 and 52 weeks
Rate of Self-reported Hypoglycemic Events up to 52 Weeks
Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). 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 With Adjudicated Cardiovascular Events up to 52 Weeks
Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. 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 With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Measured: Baseline through 4 weeks after last dose
Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
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, 52 weeks, and 4 weeks after last dose. 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, 52 weeks, and 4 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionSep 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 (4)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
- None (open label)
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191268
- Sponsor's protocol ID
- 11376
- Other IDs
- H9X-MC-GBDD
- Status last verified
- Oct 2014
- First submitted
- 27 Aug 2010
- Last updated
- 8 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.
PubMed 29430801Boustani 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 27161178Yu 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 26691396Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.
PubMed 26009229
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)
- ClinicalTrials.gov ID
- NCT01191268
- Acronym / sponsor ID
- 11376
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Posted 8 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
Detailed description
The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.5 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Insulin LisproLY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| 0.75 mg LY2189265 | Experimental | Drug: LY2189265, Drug: Insulin LisproLY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| Insulin Glargine | Active comparator | Drug: Insulin Glargine, Drug: Insulin LisproInsulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) 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 (9 listed)
- Type 2 diabetes
- Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
- Willing to inject subcutaneous medication
- Willing to monitor blood glucose levels and adjust insulin dose
Key exclusion criteria (17 listed)
- Type 1 Diabetes
- Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
- 1 or more episodes of ketoacidosis within 6 months prior to screening
- Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
- Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
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 |
|---|---|---|
| Insulin Glargine | Drug | Insulin Glargine |
| LY2189265Also: Dulaglutide | Drug | 0.75 mg LY2189265, 1.5 mg LY2189265 |
| Insulin Lispro | Drug | 0.75 mg LY2189265, 1.5 mg LY2189265, Insulin Glargine |
Primary outcome
Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 26 weeks
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
29 secondary outcomes
Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 52 weeks
Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52
Time frame: 26 weeks and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose
Time frame: Baseline, 26 weeks, and 52 weeks
Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)
Time frame: Baseline and 26 weeks and 52 weeks
Change From Baseline to 26 and 52 Weeks in Body Weight
Time frame: Baseline, 26 weeks, and 52 weeks
Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the EQ-5D
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
Time frame: Baseline, 26 weeks, and 52 weeks
Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
Time frame: Baseline, 26 weeks, and 52 weeks
Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in Blood Pressure
Time frame: Baseline, 26 weeks, and 52 weeks
Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in Pulse Rate
Time frame: Baseline, 26 weeks, and 52 weeks
Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline and 52 weeks and 4 weeks after last dose
Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Time frame: Baseline, 26 weeks, and 52 weeks
Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
Time frame: Baseline, 26 weeks, and 52 weeks
Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline through 52 weeks
Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline through 26 weeks and 52 weeks
Rate of Self-reported Hypoglycemic Events up to 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks
Time frame: Baseline through 52 weeks
Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline through 4 weeks after last dose
Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
Time frame: Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29430801Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.
- 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.
- Derived from this study: PubMed 26009229Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.
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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
101 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine, LY2189265 and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 101 sites in 16 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 9 inclusion and 17 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, Hungary, Spain, Canada, Denmark and 11 more countries. 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. 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 8 Oct 2014). 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-week 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 NCT01191268, which also lists 4 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 8 Oct 2014.