Insulin Efsitora Alfa vs. Insulin Degludec for Type 2 Diabetes

(QWINT-2 Trial)

Recruiting at166 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new type of insulin (LY3209590) to see if it works better or is safer than an existing insulin (degludec) for adults with type 2 diabetes who are starting long-acting insulin for the first time. The new insulin helps manage blood sugar levels, similar to other insulins. Insulin degludec is a new-generation ultra-long-acting basal insulin developed by NovoNordisk.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults with Type 2 Diabetes starting basal insulin for the first time can join. They should have an HbA1c level between 7.0% - 10%, be on a stable diabetes medication for at least three months, and continue it during the trial. Excluded are those with recent bariatric surgery, certain blood disorders, severe hypoglycemia history, serious heart issues or weight fluctuations.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Your HbA1c level is between 7.0% and 10% at the time of screening.

I have been on a stable diabetes medication for at least 3 months.

Exclusion Criteria

I have been diagnosed with a specific type of diabetes that is not type 2.

You have had very low blood sugar episodes in the last 6 months.

My weight has changed by more than 5% in the last 3 months.

Treatment Details

Interventions

• Insulin Degludec (Insulin)
• Insulin Efsitora Alfa (Insulin)

Trial Overview The study is testing Insulin Efsitora Alfa (LY3209590) against Insulin Degludec in adults who haven't used basal insulin before to see which one works better and is safer. Participants will randomly receive either of the two insulins while continuing their current diabetes medications.

Participant Groups

Group I: Insulin Efsitora Alfa Experimental Treatment 1 Intervention

Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.

Group II: Insulin Degludec Active Control 1 Intervention

Participants will receive insulin degludec SC once daily

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University