Phase 3
Completed N=1,842
A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03495102 ↗Enrolled (actual)
1,842
Serious AEs
7.4%
Results posted
Jun 2020
Primary outcomePrimary: Change in Hemoglobin A1c (HbA1c) From Baseline — -1.53; -1.71; -1.87 Percentage of HbA1c — p=0.003
◆ Published Evidence
Highly cited
188citations · ~38 / year
Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).
Summary
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
Linked Publications (3)
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Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).
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Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
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Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c (HbA1c) From Baseline |
-1.53; -1.71; -1.87 | 0.003 sig |
| SECONDARY Change in Body Weight From Baseline |
-3.1; -4.0; -4.7 | 0.001 sig |
| SECONDARY Percentage of Participants Achieving HbA1c Target <7.0% |
56.98; 64.68; 71.48 | 0.006 sig |
| SECONDARY Change in Fasting Serum Glucose (FSG) From Baseline |
-44.2; -47.9; -52.3 | 0.084 |
| SECONDARY Rate of Documented Symptomatic Hypoglycemic Episodes |
0.02; 0.00; 0.02 | — |
| SECONDARY Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) |
79.6; 159; 238 | — |
| SECONDARY Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State |
11200; 22300; 33400 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03495102) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.