A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

• Status: Not yet recruiting
• Trial end date: 2023-10-11
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide

Criteria

Inclusion Criteria:

• Have a diagnosis of type 2 diabetes mellitus (T2DM) of at least 1-year duration currently treated with stable doses of oral antihyperglycemic medications with or without stable doses of basal or premix insulin for the last 3 months prior to screening.

• Have HbA1c ≥7.5% and ≤11.5%, both inclusive, at screening, and

• Have body mass index (BMI) ≥23 kilogram/square meter (kg/m²)

Exclusion Criteria:

• A diagnosis of type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes, or specific type of diabetes other than T2DM

• Been treated with antihyperglycemic medication like glucagon-like peptide receptor agonists (GLP-1 RA) or have a prior history of any contraindication to GLP-1 RA therapy within 3 months prior to screening, or eGFR <15 milliliter/minute (ml/min)/1.73 square meter (m²)

• Participants have known hypersensitivity or allergy to dulaglutide or its excipients.

• Participants are on systemic steroids for any period of more than 14 days.

• Participants have severe gastrointestinal (GI) disease, including severe gastroparesis.

• Participants have an active or untreated malignancy, except for successfully treated basal or squamous cell carcinoma.