A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2023-02-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: 2,4-thiazolidinedione; Biguanides; Dulaglutide; Glycoside Hydrolase Inhibitors

Criteria

Inclusion Criteria:

• Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.

• Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.

• Have the following HbA1c result at screening.

• Participants taking DPP-4i: ≥7.5% and ≤9.5%,

• Participants taking another OAM: ≥8.0% and ≤10.0%

• Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks

• Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion Criteria:

• Have type 1 diabetes (T1D)

• Have a history of ≥1 episode of ketoacidosis or hyperosmola state/coma

• Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)

• Have a known clinically significant gastric empty abnormality

• Have acute or chronic hepatitis

• Have had chronic or acute pancreatitis

• Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia

• Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)

• Have evidence of significant, active autoimmune abnormality

• Have evidence of significant, uncontrolled endocrine abnormality

• Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years

• Have any hematologic condition that may interfere with HbA1c measurement