A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)

I8H-MC-BDCV -

The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 2 diabetes
What the trial is testing?
LY3209590, Insulin Lispro, Insulin Glargine, Insulin Efsitora Alfa
Could I receive a Placebo?
No
Enrollment Goal
730
Trial Dates
Aug 11, 2022 - Feb 27, 2024
How long will I be in the trial?
Your participation could last about 34 weeks and may include up to total 25 visits (13 visits to the study center and 12 telehealth visits).
Trial Phase
III

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 (T2DM)

  • Participants must be receiving stable dose of long-acting insulin and at least 2 injections of mealtime insulin per day for 90 days

  • Participants must be taking diabetes medication for 3 months before entering the study

  • Participants must have stable body weight for the last three months

Participants Must Not:

  • Participants must not have type 1 diabetes mellitus (T1DM)

  • Participants must not have received any of the following insulin therapies in the past 90 days- insulin mixtures, inhaled insulin, insulin pump therapy, or regular insulin U-500

  • Participants must not have received certain nonallowed oral diabetes medication within prior 90 days

  • Participants must not have had an episode of very low blood glucose level within the last 6 months of starting the study

  • Participants must not have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months

  • Participants must not have lost or gained significant weight in the last 3 months

  • Participants must not have known liver disease

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