A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Biguanides; Dulaglutide; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening

• Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable

• Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening

• Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)

Exclusion Criteria:

• Participants who have a diagnosis of type 1 diabetes

• Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog

• Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening

• Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening

• Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening

• Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)