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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin Glargine; Drug: LY3209590

• Registration Number: NCT04957914
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-12
• Study Start: 2021-07-14
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2022-11-01
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Insulin Glargine (Period 1)	Insulin Glargine	Insulin glargine administered subcutaneously (SC).
LY3209590 (Period 2)	LY3209590	LY3209590 administered SC.

Primary Outcome Measures

Name	Time	Method
Incidence of Documented Hypoglycemia	Baseline through Day 186	Incidence of Documented Hypoglycemia

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany