A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

I8H-MC-BDCW -

The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
LY3209590, Insulin Glargine, Insulin Efsitora Alfa
Could I receive a Placebo?
No
Enrollment Goal
795
Trial Dates
Jan 14, 2023 - Jul 17, 2024
How long will I be in the trial?
The study will last about 60 weeks and may include up to 35 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:

  • Have type 2 diabetes

  • Have HbA1c of 7.0% to 10% inclusive at screening

  • Are currently taking at least 1 antihyperglycemic medication for at least 3 months

  • Are insulin naive

Participants Must Not:

  • Have type 1 diabetes

  • Have a history of >1 episode of ketoacidosis or or coma requiring hospitalization within 6 months prior to screening

  • Have had severe hypoglycemia episodes within 6 months prior to screening

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Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.