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

November 15, 2022 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Neuss, Nordrhein-Westfalen, Germany, 41460
        • Profil Institut für Stoffwechselforschung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Insulin Glargine (Period 1)
Insulin glargine administered subcutaneously (SC).
Drug: Insulin Glargine
Administered SC
EXPERIMENTAL: LY3209590 (Period 2)
LY3209590 administered SC.
Drug: LY3209590
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Documented Hypoglycemia
Time Frame: Baseline through Day 186
Incidence of Documented Hypoglycemia
Baseline through Day 186

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 14, 2021

Primary Completion (ACTUAL)

October 17, 2022

Study Completion (ACTUAL)

October 17, 2022

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (ACTUAL)

July 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16936
  • I8H-MC-BDCI (OTHER: Eli Lilly and Company)
  • 2019-003537-42 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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