Primary outcomeLeast squares mean· Baseline, Week 36
Change in Hemoglobin A1c (HbA1c) From Baseline
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -1.53 | 0.04 |
| Dulaglutide 3 mg | -1.71 | 0.04 |
| Dulaglutide 4.5 mg | -1.87 | 0.04 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Short name AWARD-11
NCTNCT03495102 (opens ClinicalTrials.gov in a new tab)Other id16877Other idH9X-MC-GBGLOther id2017-003490-33Other id2017
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 1,842 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
16 countries
United States, Argentina, Austria, Canada, Greece, Hungary, Israel, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, Spain, Taiwan
- Start
- 5 Apr 2018
- Primary completion
- 28 May 2019
- Completion
- 10 Oct 2019
- First posted
- 11 Apr 2018
- Last update posted
- 12 Jun 2020
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- DulaglutideDrug
Arms3
Active comparator
Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Experimental
Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
Experimental
Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Hemoglobin A1c (HbA1c) From Baseline
Time frame · Baseline, Week 36
Registry description
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).
Secondary outcomes(6)
Change in Body Weight From Baseline
Time frame · Baseline, Week 36
Registry description
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
Registry description
Percentage of participants achieving HbA1c target \<7.0%.
Change in Fasting Serum Glucose (FSG) From Baseline
Time frame · Baseline, Week 36
Registry description
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
Registry description
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
Registry description
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
Registry description
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Baseline, Week 36
Change in Body Weight From Baseline
| Group | Value (Kilograms (Kg)) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -3.1 | 0.19 |
| Dulaglutide 3 mg | -4.0 | 0.19 |
| Dulaglutide 4.5 mg | -4.7 | 0.19 |
Secondary outcomeNumber· Week 36
Percentage of Participants Achieving HbA1c Target <7.0%
| Group | Value (percentage of participants) |
|---|---|
| Dulaglutide 1.5 mg | 56.98 |
| Dulaglutide 3 mg | 64.68 |
| Dulaglutide 4.5 mg | 71.48 |
Secondary outcomeLeast squares mean· Baseline, Week 36
Change in Fasting Serum Glucose (FSG) From Baseline
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -44.2 | 1.50 |
| Dulaglutide 3 mg | -47.9 | 1.50 |
| Dulaglutide 4.5 mg | -52.3 | 1.50 |
Secondary outcomeMean· Week 36
Rate of Documented Symptomatic Hypoglycemic Episodes
| Group | Value (Episodes/participant/365.25 days) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | 0.02 | 0.01 |
| Dulaglutide 3 mg | 0.00 | 0.00 |
| Dulaglutide 4.5 mg | 0.02 | 0.01 |
Secondary outcomeMean· Week 4, Week 12, Week 36, Week 52
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
| Group | Value (nanogram/milliliter (ng/mL)) |
|---|---|
| Dulaglutide 1.5 mg | 79.6 |
| Dulaglutide 3 mg | 159 |
| Dulaglutide 4.5 mg | 238 |
Secondary outcomeMean· Week 4, Week 12, Week 36, Week 52
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State
| Group | Value (nanogram*hour/milliliter (ng*h/mL)) |
|---|---|
| Dulaglutide 1.5 mg | 11200 |
| Dulaglutide 3 mg | 22300 |
| Dulaglutide 4.5 mg | 33400 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dulaglutide 1.5 mgDulaglutide 1.5 mg administered subcutaneously (SC) once a week. | 3 / 612 | 53 / 612 | 156 / 612 |
| Dulaglutide 3 mgDulaglutide 3 mg administered SC once a week. | 4 / 616 | 45 / 616 | 190 / 616 |
| Dulaglutide 4.5 mgDulaglutide 4.5 mg administered SC once a week. | 4 / 614 | 38 / 614 | 195 / 614 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies3
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2022
9 results
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.
Cox et al. 2022Diabetes, obesity & metabolismcited by 4
PMID 35546790PMC9543252DOI 10.1111/dom.14762PUB-35546790
Free to read · publisher termsCC BY-NC9 results
Indexing hint: Randomized controlled trial · 2021
12 results
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).
Frias et al. 2021Diabetes carecited by 148
PMID 33397768PMC7896253DOI 10.2337/dc20-1473PUB-33397768
Rights unknown12 results
More studies
1 study on this page
Indexing hint: Meta-analysis (pooled) · 2023
Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Ferdinand et al. 2023Cardiovascular diabetologycited by 12
PMID 36894938PMC9999488DOI 10.1186/s12933-023-01775-xPUB-36894938
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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