Phase 3
Completed N=599
A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01624259 ↗Enrolled (actual)
599
Serious AEs
2.7%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) — -1.42; -1.36 percentage of glycosylated hemoglobin — p=<0.001
Summary
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.42; -1.36 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at 26 Weeks |
-2.90; -3.61 | 0.010 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at 26 Weeks |
-1.05; -1.30 | 0.013 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks |
-34.81; -34.25 | 0.828 |
| SECONDARY Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks |
-40.76; -38.51 | 0.228 |
| SECONDARY Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks |
54.6; 50.9; 68.3; 67.9 | 0.322 |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks |
37.03; 35.59 | 0.608 |
| SECONDARY Number of Participants With Reported and Adjudicated Cardiovascular Events |
0; 3; 0; 1; 0; 0 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks |
1.9; 4.1 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks |
3.8; 3.3; 0.39; -0.72 | — |
| SECONDARY Change From Baseline in Heart Rate (HR) at 26 Weeks |
2.37; 3.12 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at 26 Weeks |
-0.22; -0.31; -3.36; -2.82 | — |
| SECONDARY Number of Participants With Adjudicated Acute Pancreatitis Events |
0; 0 | — |
| SECONDARY Change From Baseline in Calcitonin at 26 Weeks |
0.00; 0.00 | — |
| SECONDARY Change From Baseline in Lipase at 26 Weeks |
7.0; 11.0 | — |
| SECONDARY Change From Baseline in Amylase at 26 Weeks |
7.0; 6.0 | — |
| SECONDARY Percentage of Participants With Self-Reported Hypoglycemia Events |
2.7; 2.7; 6.7; 3.3; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia |
0.3; 1.0 | — |
| SECONDARY Rate of Hypoglycemic Events Adjusted Per 30 Days |
0.03; 0.04; 0.01; 0.02; 0.02; 0.01 | — |
| SECONDARY Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia |
NA; NA | — |
| SECONDARY Number of Participants With Allergic or Hypersensitivity Reactions |
1; 5 | — |
| SECONDARY Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose |
3 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters at 26 Weeks |
-1.64; 0.67; 6.21; 6.46; -1.09; 3.20 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
- Accept continued treatment with metformin throughout the trial, as required per protocol
- Men and nonpregnant women aged greater than or equal to 18 years
- Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
- Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)
Exclusion Criteria
- Have type 1 diabetes mellitus
- Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 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 use within 3 months prior to the first study visit
- Have been treated with drugs that promote weight loss within 3 months of the first study visit
- Are receiving chronic (greater than 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 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 (such as, 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 greater than or equal to 3 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 a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) 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, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)
Data sourced from ClinicalTrials.gov (NCT01624259). 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.