A Study of LY3209590 in Participants With Type 1 Diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-003589-41-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-09
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year.
• Participants must have been using multiple daily injections without interruption for at least 3 months.
• Participants must have HbA1c value of =9.5%.
• Participants must have a body mass index (BMI) of =35 kilograms per meter squared (kg/m²).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 209
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion Criteria

• Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening.
• Participants must not have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
• Participants must not have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke).
• Participants must not have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease.
• Participants must not have estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m².
• Participants must not have active or untreated cancer.
• Participants must not be on chronic (>14 days) systemic glucocorticoid therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified