A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

• Status: Completed
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year.

• Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).

• Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.

• Have a screening body weight of ≥50 and ≤80 kilograms.

Exclusion Criteria:

• Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.

• Have had a clinically significant cardiovascular disease.

• Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.

• Have acute or chronic hepatitis, signs and symptoms of any other liver disease.

• Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.

• Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared.

• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.