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NCT04957914 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Effects of LY3209590 on Frequency and Severity of Hypoglycaemia Under Conditions of Increased Hypoglycaemic Risk Compared to Insulin Glargine in Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04957914
Other study ID # 16936
Secondary ID I8H-MC-BDCI2019-
Status Completed
Phase Phase 1
First received
Last updated
Start date July 14, 2021
Est. completion date October 17, 2022

Study information
Verified date November 1, 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date October 17, 2022
Est. primary completion date October 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin Glargine
Administered SC
• LY3209590
Administered SC

Locations
Country Name City State
Germany Profil Institut für Stoffwechselforschung Neuss Nordrhein-Westfalen

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Documented Hypoglycemia Incidence of Documented Hypoglycemia Baseline through Day 186
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