A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (AWARD-11)
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|ClinicalTrials.gov Identifier: NCT03495102|
Recruitment Status : Completed
First Posted : April 11, 2018
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Dulaglutide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1842 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||April 5, 2018|
|Actual Primary Completion Date :||May 28, 2019|
|Actual Study Completion Date :||October 10, 2019|
Active Comparator: Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Other Name: LY2189265
Experimental: Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
Other Name: LY2189265
Experimental: Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
Other Name: LY2189265
- Change in Hemoglobin A1c (HbA1c) From Baseline [ Time Frame: Baseline, Week 36 ]HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
- Change in Body Weight From Baseline [ Time Frame: Baseline, Week 36 ]Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
- Percentage of Participants Achieving HbA1c Target <7.0% [ Time Frame: Week 36 ]Percentage of participants achieving HbA1c target <7.0%.
- Change in Fasting Serum Glucose (FSG) From Baseline [ Time Frame: Baseline, Week 36 ]Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).
- Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Week 36 ]Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
- Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) [ Time Frame: Week 4, Week 12, Week 36, Week 52 ]Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
- Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State [ Time Frame: Week 4, Week 12, Week 36, Week 52 ]Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have type 2 diabetes mellitus (T2DM) for at least 6 months
- Have been treated with stable metformin dose for at least 3 months
- Have HbA1c ≥7.5% and ≤11.0% at study entry
- Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)
- Have type 1 diabetes mellitus
- Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
- Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
- Have used in the last 3 months (or plan to use) prescription weight loss medications
- Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
- Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
- Had chronic or acute pancreatitis any time prior to study entry
- Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
- Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495102
|Study Director:||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)||Eli Lilly and Company|
Documents provided by Eli Lilly and Company:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
H9X-MC-GBGL ( Other Identifier: Eli Lilly and Company )
2017-003490-33 ( EudraCT Number )
|First Posted:||April 11, 2018 Key Record Dates|
|Results First Posted:||June 12, 2020|
|Last Update Posted:||June 12, 2020|
|Last Verified:||December 15, 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.|
|Access Criteria:||A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs