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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

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