A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Glimepiride; Immunoglobulin Fc Fragments

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)