Phase 3
Completed N=737
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01644500 ↗Enrolled (actual)
737
Serious AEs
1.8%
Results posted
Dec 2015
Primary outcomePrimary: Change From Baseline in HbA1c at 26 Weeks — -1.48; -1.22; -0.92 percentage of HbA1c — p=<0.001
Summary
The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at 26 Weeks |
-1.48; -1.22; -0.92 | <0.001 sig |
| SECONDARY Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks |
59.4; 47.7; 41.3; 74.1; 63.6; 57.4 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks |
-2.71; -2.26; -1.89 | <0.001 sig |
| SECONDARY Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks |
-2.47; -1.91; -1.80; -4.56; -3.75; -3.20 | <0.001 sig |
| SECONDARY Rate of Hypoglycemic Episodes |
0.01; 0.01; 0.09; NA; NA; NA | <0.001 sig |
| SECONDARY Number of Participants With Self-Reported Hypoglycemic Episodes |
14; 9; 38 | <0.001 sig |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks |
47.40; 37.92; 30.00; 41.02; 34.57; 24.58 | <0.001 sig |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks |
-6.85; -10.33; -7.19; -6.44; -11.84; -5.05 | 0.913 |
| SECONDARY Change From Baseline in Pancreatic Enzymes at 26 Weeks |
9.29; 7.04; 3.79; 6.19; 4.92; 2.64 | — |
| SECONDARY Change From Baseline in Serum Calcitonin at 26 Weeks |
-0.01; -0.02; 0.02 | — |
| SECONDARY Change From Baseline in Sitting Blood Pressure at 26 Weeks |
-2.07; -1.88; -0.66; -0.10; -0.11; 0.15 | 0.180 |
| SECONDARY Change From Baseline in Sitting Pulse Rate at 26 Weeks |
3.07; 1.24; -0.34 | <0.001 sig |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks |
-6.18; -2.06; 1.21; 3.73; 3.29; -0.23 | — |
| SECONDARY Change From Baseline in Heart Rate From ECG at 26 Weeks |
3.99; 1.90; 0.44 | — |
| SECONDARY Change From Baseline in Body Weight at 26 Weeks |
-1.46; -0.77; 0.89 | <0.001 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at 26 Weeks |
-0.55; -0.29; 0.32 | <0.001 sig |
| SECONDARY Percentage of Participants Developing Antibodies to Dulaglutide |
17; 8; 4 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events |
0; 1; 0 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis |
7; 5; 1 | — |
| SECONDARY European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks |
217; 218; 224; 4; 3; 6 | — |
| SECONDARY Visual Analog Scale (VAS) Score at 26 Weeks |
85.72; 86.17; 85.96 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- OAM-naïve or have been taking OAM monotherapy for at least 3 months
- Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy
- Adult men or adult non-pregnant, non-breastfeeding women
- Stable weight (±5%) ≥3 months prior to screening
- Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have type 1 diabetes mellitus
- Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
- Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
- 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 millimeters 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 picogram/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 (NCT01644500). 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.