A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

I8H-MC-BDCL -

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

Trial Summary

Age Range
18 - 75 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Insulin Degludec, LY3209590
Could I receive a Placebo?
No
Enrollment Goal
278
Trial Dates
Jul 1, 2020 - Oct 8, 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 type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of a Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor) for at least 3 months prior to screening

  • Participants must have a HbA1c value of 7.0% to 9.5%, inclusive

  • Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Participants Must Not:

  • Participants must not have type 1 diabetes mellitus or latent autoimmune diabetes

  • 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 an 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

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