A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin Glargine

Drug: LY3209590

Study type

Interventional

Funder types

Industry

Identifiers

NCT04957914

16936

I8H-MC-BDCI (Other Identifier)

2019-003537-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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