Phase 3
Completed N=774
A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01648582 ↗Enrolled (actual)
774
Serious AEs
6.3%
Results posted
Jul 2015
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks — -1.73; -1.33; -1.16 percentage of HbA1c
Summary
The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks |
-1.73; -1.33; -1.16 | — |
| SECONDARY Change From Baseline in HbA1c at 52 Weeks |
-1.47; -1.03; -0.89 | — |
| SECONDARY Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks |
64.8; 52.8; 40.0; 51.4; 38.9; 21.6 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks |
-2.35; -1.71; -2.59; -2.23; -1.53; -2.35 | 0.177 |
| SECONDARY Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks |
-2.18; -1.89; -2.83; -3.81; -3.43; -3.32 | <0.001 sig |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks |
34.41; 31.17; 45.12; 36.64 | 0.352 |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks |
-6.86; -10.03; -10.19; -12.32 | 0.025 sig |
| SECONDARY Rate of Hypoglycemic Events |
1.27; 0.98; 2.13; NA; NA; NA | — |
| SECONDARY Number of Self-reported Hypoglycemic Events |
19.4; 16.7; 29.6; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP) |
-5.53; -2.77; -2.22; -1.58; -0.92; -1.61 | 0.008 sig |
| SECONDARY Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate |
4.63; 0.65; -0.86; 4.18; 3.18; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
-1.65; 0.76; 2.56; 3.09; 2.88; -0.86 | — |
| SECONDARY Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR) |
6.13; 3.77; -0.46; 5.04; 3.40; 0.43 | — |
| SECONDARY Change From Baseline in Pancreatic Enzymes |
7.50; 7.54; -0.37; 5.83; 5.14; -0.21 | — |
| SECONDARY Change From Baseline in Serum Calcitonin |
0.01; -0.07; 0.02; -0.03; -0.08; -0.05 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular (CV) Events |
6; 2; 2 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight |
-1.47; -0.88; 0.97; -1.08; -0.76; 1.35 | <0.001 sig |
| SECONDARY Change in Body Mass Index |
-0.53; -0.32; 0.37; -0.40; -0.27; 0.52 | <0.001 sig |
| SECONDARY Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA) |
3.9; 4.3; 1.6; 0.8; 1.6; 0.0 | — |
| SECONDARY EQ-5D Health State Score Responses |
219; 215; 210; 7; 16; 20 | — |
| SECONDARY Change From Baseline in EQ-5D Visual Analog Scale Score |
1.08; 1.67; 1.41; 2.65; 2.34; 2.55 | — |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes mellitus for at least 6 months
- Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
- Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
- Adult men or adult non-pregnant, non-breastfeeding women
- Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)
- Stable weight (±5%) ≥3 months prior to screening
Exclusion Criteria
- Have type 1 diabetes mellitus
- Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
- Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
- Have gastric emptying abnormality
- Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
- Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)
- Have impaired liver function
- Have impaired kidney function
- Have history of chronic pancreatitis or acute pancreatitis
- Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)
- Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)
Data sourced from ClinicalTrials.gov (NCT01648582). 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.