Diabetes Mellitus, Type 2Phase 3AWARD-9NCT02152371
A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes
A Phase 3 study testing Dulaglutide, Insulin Glargine and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 40 sites in 7 countries.
Trial summary
The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant. 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?
- Dulaglutide, Insulin Glargine 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
- 300 participants
- Where
- 40 sitesin 7 countries
- Study dates
- May 2014to Oct 2015
- 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
- Have type 2 diabetes (based on the World Health Organization's [WHO] diagnostic criteria)
- Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening
- Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label
- Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening
- Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week
- Have stable weight (±5%) ≥3 months prior to screening
Show all 12Show fewer
- Have body mass index (BMI) ≤45 kilograms per square meter (kg/m^2) at screening
- Are able and willing to administer once weekly randomized therapy
- Are females of childbearing potential who must:
- Test negative for pregnancy at screening, based on a serum pregnancy test
- Agree to use a reliable method of birth control
- Not be breastfeeding
Who cannot join
- Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3
- Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
- Have a history of hypoglycemia unawareness within the 6 months prior to screening
- Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3
- Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3
- Have had any of the following cardiovascular conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
Show all 20Show fewer
- Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory
- Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening
- Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter (mL/min/m^2), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum creatinine ≥1.5 mg/deciliter [dL] [male] or ≥1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m^2)
- Have evidence of a significant, uncontrolled endocrine abnormality
- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia
- Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- Have serum calcitonin ≥20 picograms/mL, as determined by the central laboratory
- Have evidence of a significant, active autoimmune abnormality
- Have any other condition not listed in this section that is a contraindication for use of insulin glargine, or, for participants using metformin, have a condition that is a contraindication for the use of metformin and would require metformin discontinuation per label
- Have a history of transplanted organ
- Have a history of active or untreated malignancy, or are in remission from a clinically significant malignancy during the 5 years prior to screening
- Have a history of any other condition which, in the opinion of the investigator, may preclude the participants from following and completing the protocol
- Have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
United States13 sites
Northwest Endo Diabetes Research, LLC
Arlington Heights, Illinois, 60005
Valley Endocrine, Fresno
Fresno, California, 93720
Bland Clinic, PA
Greensboro, North Carolina, 27401
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
PMG Research of Knoxville
Knoxville, Tennessee, 37912
AB Clinical Trials
Las Vegas, Nevada, 89119
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
Rainier Clinical Research Center
Renton, Washington, 98057
Mills-Peninsula Diabetes Research Insitute
San Mateo, California, 94401
Polyclinic
Seattle, Washington, 98104
SHS Clinical Research Group
Toms River, New Jersey, 08753
Cotton O'Neil Clinic
Topeka, Kansas, 66606
University Clinical Investigators, Inc.
Tustin, California, 92780
Puerto Rico6 sites
Centro de Endocrinologia y Nutricion del Turabo
Caguas, 00726
Manati Center for Clinical Research Inc
Manati, 00674
Ponce School of Medicine CAIMED Center
Ponce, 00716
Endocrine Lipid Diabetes Research Institute
Ponce, 00717-2075
GCM Medical Group PSC
San Juan, 00909
American Telemedicine Center
San Juan, 00917-3104
Czechia5 sites
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Beroun, 26601
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Brandys Nad Labem-Stara Bolesl, 25001
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České Budějovice, 370 01
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Krnov, 79401
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Prague, 149 00
Spain5 sites
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Alzira, 46600
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Cadiz, 11540
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Madrid, 28223
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Seville, 41010
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Teruel, 44002
Italy4 sites
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Monza, 20900
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Olbia, 07026
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Pisa, 56126
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Rome, 00128
United Kingdom4 sites
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Guildford, Surrey, GU2 7XX
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Leicester, Leicestershire, LE5 4PW
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Mortimer, Berks, RG7 3SQ
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Swansea, Wales, SA6 6NL
Hungary3 sites
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Budapest, 1139
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Debrecen, 4043
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Nagykanizsa, 8800
About this study
Official title: A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine
The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dulaglutide, Placebo, Insulin Glargine, Metformin
- 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.
DulaglutideDrug
Also called LY2189265
Administered SQ
PlaceboDrug
Administered SQ
Insulin GlargineDrug
Administered SQ
MetforminDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide + Insulin Glargine | Experimental | 1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses. Receives: Drug: Dulaglutide; Drug: Insulin Glargine; Drug: Metformin |
| Placebo + Insulin Glargine | Placebo comparator | Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses. Receives: Drug: Placebo; Drug: Insulin Glargine; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.
Measured: Baseline, 28 Weeks
Secondary outcomes (15)
Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)
FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.
Measured: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.
Measured: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in Body Weight
LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.
Measured: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose
Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.
Measured: Baseline, 28 Weeks
Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events
Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).
Measured: Baseline through 28 Weeks
Percentage of Participants With Self-Reported Events of Hypoglycemia
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 =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<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 percentage of participants with self-reported hypoglycemic events is presented.
Measured: Baseline through 28 Weeks
Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia
Measured: Baseline through 28 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through 28 Weeks
Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)
Measured: Baseline through 28 Weeks
Number of Participants With Dulaglutide Anti-Drug Antibodies
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Measured: Baseline, Week 12 and Week 28
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%
Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.
Measured: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.
Measured: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL.
Measured: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)
Measured: 28 Weeks
Rate of Hypoglycemic Events up to 28 Weeks
The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.
Measured: Baseline through 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
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 (2)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 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
- NCT02152371
- Sponsor's protocol ID
- 13195
- Other IDs
- H9X-MC-GBDI, 2012-004229-25
- Acronym
- AWARD-9
- Status last verified
- Sep 2019
- First submitted
- 28 May 2014
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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 29430801Yu M, Brunt KV, Milicevic Z, Varnado O, Boye KS. Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9). Clin Ther. 2017 Nov;39(11):2284-2295. doi: 10.1016/j.clinthera.2017.10.002. Epub 2017 Oct 27.
PubMed 29110972
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine
- ClinicalTrials.gov ID
- NCT02152371
- Acronym / sponsor ID
- AWARD-9 / 13195
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Posted 7 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide + Insulin Glargine | Experimental | Drug: Dulaglutide, Drug: Insulin Glargine, Drug: Metformin1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses. |
| Placebo + Insulin Glargine | Placebo comparator | Drug: Placebo, Drug: Insulin Glargine, Drug: MetforminPlacebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have type 2 diabetes (based on the World Health Organization's [WHO] diagnostic criteria)
- Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening
- Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label
- Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening
- Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week
Key exclusion criteria (20 listed)
- Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3
- Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
- Have a history of hypoglycemia unawareness within the 6 months prior to screening
- Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3
- Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3
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 |
|---|---|---|
| DulaglutideAlso: LY2189265Administered SQ | Drug | Dulaglutide + Insulin Glargine |
| PlaceboAdministered SQ | Drug | Placebo + Insulin Glargine |
| Insulin GlargineAdministered SQ | Drug | Dulaglutide + Insulin Glargine, Placebo + Insulin Glargine |
| MetforminAdministered orally | Drug | Dulaglutide + Insulin Glargine, Placebo + Insulin Glargine |
Primary outcome
Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 28 Weeks
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.
15 secondary outcomes
Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)
Time frame: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Time frame: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in Body Weight
Time frame: Baseline, 28 Weeks
Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose
Time frame: Baseline, 28 Weeks
Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events
Time frame: Baseline through 28 Weeks
Percentage of Participants With Self-Reported Events of Hypoglycemia
Time frame: Baseline through 28 Weeks
Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia
Time frame: Baseline through 28 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
Time frame: Baseline through 28 Weeks
Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)
Time frame: Baseline through 28 Weeks
Number of Participants With Dulaglutide Anti-Drug Antibodies
Time frame: Baseline, Week 12 and Week 28
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%
Time frame: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
Time frame: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
Time frame: 28 Weeks
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)
Time frame: 28 Weeks
Rate of Hypoglycemic Events up to 28 Weeks
Time frame: Baseline through 28 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- 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 29110972Yu M, Brunt KV, Milicevic Z, Varnado O, Boye KS. Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9). Clin Ther. 2017 Nov;39(11):2284-2295. doi: 10.1016/j.clinthera.2017.10.002. Epub 2017 Oct 27.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dulaglutide, Insulin Glargine and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 40 sites in 7 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 12 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Puerto Rico, Czechia, Spain, Italy and 2 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. 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 7 Dec 2016). 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 28 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 28 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 NCT02152371, which also lists 2 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 25 Sep 2019.