Phase 3
Completed N=300
Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
Source: ClinicalTrials.gov NCT01769378 ↗Enrolled (actual)
300
Serious AEs
3.0%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks — -1.38; -0.11 percent change of HbA1c — p=<0.001
Summary
The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks |
-1.38; -0.11 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks |
55.3; 18.9; 40.0; 9.4 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks |
-30.60; 2.93 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at 24 Weeks |
-0.91; -0.24 | 0.120 |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at 24 Weeks |
-0.32; -0.10 | 0.161 |
| SECONDARY Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks |
-37.22; -8.27 | <0.001 sig |
| SECONDARY Number of Participants With Reported and Adjudicated Cardiovascular Events |
2; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Acute Pancreatitis Events |
0; 0 | — |
| SECONDARY Change From Baseline in Calcitonin at 24 Weeks |
0.00; 0.00 | — |
| SECONDARY Percentage of Participants With Self-Reported Events of Hypoglycemia |
11.3; 1.7; 13.4; 1.7; 2.5; 0.0 | — |
| SECONDARY Rate of HE Adjusted Per 30 Days |
0.19; 0.01; 0.07; 0.00; 0.11; 0.00 | — |
| SECONDARY Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia |
2.1; 11.7 | — |
| SECONDARY Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia |
22.59; 22.47 | — |
| SECONDARY Dulaglutide Anti-Drug Antibodies (ADA) |
2 | — |
| SECONDARY Change From Baseline in Lipase |
8.0; 4.5 | — |
| SECONDARY Change From Baseline in Amylase |
8.0; 2.0 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit
- Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit
- Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol
- Men and nonpregnant women aged ≥18 years
- Stable weight (±5%) ≥3 months prior to screening
- Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have type 1 diabetes mellitus
- Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months prior to the first study visit
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary
- Have been treated with drugs that promote weight loss within 3 months prior to the first study visit
- Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
- Have had any of the following Cardiovascular (CV) conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
- Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level >2.5 times the upper limit of normal
- Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
- Have an estimated glomerular filtration rate [eGFR] <30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation as determined by the central laboratory at the first study visit
- 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 (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
- Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
- Have a serum calcitonin ≥20 picogram per milliliter (pg/mL) as determined by the central laboratory at the first study visit
Data sourced from ClinicalTrials.gov (NCT01769378). 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.