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Completed

NCT Number: NCT04957914

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

Administered SC

LY3209590

Drug

Administered SC

Primary outcomes

  1. Incidence of Documented Hypoglycemia

    Time frame: Baseline through Day 186

    Incidence of Documented Hypoglycemia

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2021
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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