A Multiple-Dose Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

• Status: Recruiting
• Trial end date: 2022-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the effect of study drug known as LY3209590 compared to insulin glargine administered in participants with type 2 diabetes mellitus (T2DM). Side effects and tolerability will be documented. The study will last almost six months and 21 visits for each participant including screening period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

• Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 1 year prior to screening

• Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)

• Be treated for T2DM with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening

Exclusion Criteria:

• Have an abnormality in the 12-lead ECG

• Have a supine blood pressure at screening

• Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit of normal (ULN)

• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (except T2DM and controlled thyroid disease), haematological, or neurological disorders

• Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy

• Have an average weekly alcohol intake