A Study of LY3209590 in Participants With Type 1 Diabetes

I8H-MC-BDCP -

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 1 Diabetes
What the trial is testing?
Insulin Degludec, LY3209590
Could I receive a Placebo?
No
Enrollment Goal
266
Trial Dates
Jul 6, 2020 - Oct 1, 2021
How long will I be in the trial?
The study will last about 33 weeks and may include up to 21 visits.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • 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 values of 5.6% to 9.5%, inclusive

  • Participants must have a body mass index (BMI) of 35 kilograms per meter squared (kg/m²)

Participants Must Not:

  • 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

Lilly Trial Alerts

Not the right fit? Sign up to receive updates about new trials that are listed or when a new trial site begins enrolling near you.