Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments dulaglutide, insulin glargine, metformin, sulfonylureas
Phase phase 3
Sponsor Eli Lilly and Company
Start date July 2012
End date May 2014
Trial size 789 participants
Trial identifier NCT01648582, 13439, H9X-CR-GBDK

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 one or two oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea) in addition to any healthy lifestyle changes recommended by their healthcare providers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1.5 milligrams (mg) Dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea. Participants are blinded to the Dulaglutide dose.
dulaglutide LY2189265
Administered SC
metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
(Experimental)
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea. Participants are blinded to the Dulaglutide dose.
dulaglutide LY2189265
Administered SC
metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
(Active Comparator)
Insulin Glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
insulin glargine
Administered SC per dosing titration schedule
metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

Primary Outcomes

Measure
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
time frame: Baseline, 26 Weeks

Secondary Outcomes

Measure
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks
time frame: Baseline, 52 Weeks
Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks
time frame: 26 Weeks and 52 Weeks
Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β)- cell function (HOMA2-%B) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Rate of Hypoglycemic Episodes
time frame: Baseline through 26 Weeks and Baseline through 52 Weeks
Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks
Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks and 52 Weeks
time frame: Baseline, 26 Weeks, 52 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 - 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 dipeptidylpeptidase-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) - Impaired liver function - 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)

Additional Information

Official title The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.