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Insulin

Insulin Efsitora Alfa vs. Insulin Degludec for Type 2 Diabetes (QWINT-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have diagnosis of T2D according to the World Health Organization Criteria
Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48 to week 52
Awards & highlights

QWINT-2 Trial Summary

This trial is testing a new insulin compared to another existing insulin, to see which is more effective and safe for adults with type 2 diabetes who have never used insulin before.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at injection sites, weight changes, swelling in arms or legs, and possibly other unknown risks that come with new treatments.

QWINT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes.
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I have been on a stable diabetes medication for at least 3 months.

QWINT-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Change from Baseline in Fasting Glucose
+8 more

QWINT-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Efsitora AlfaExperimental Treatment1 Intervention
Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
Group II: Insulin DegludecActive Control1 Intervention
Participants will receive insulin degludec SC once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Efsitora Alfa
2022
Completed Phase 3
~3340

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Basal insulin analogs, like insulin efsitora alfa, provide a steady level of insulin throughout the day and night, helping to maintain stable blood glucose levels and reduce the risk of hyperglycemia in Type 2 Diabetes patients. Other treatments, such as GLP-1 receptor agonists and DPP-4 inhibitors, enhance insulin secretion, inhibit glucagon release, and prolong the action of incretin hormones. These mechanisms are crucial as they address insulin resistance and impaired insulin secretion, improving glycemic control and reducing complications associated with Type 2 Diabetes.
Clinical Implications of Cardiovascular Outcome Trials in Type 2 Diabetes: From DCCT to EMPA-REG.[Significance of combination therapy with an insulin sensitizer and a DPP-4(dipeptidyl peptidase-4) inhibitor].Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,627 Previous Clinical Trials
3,216,945 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,548 Total Patients Enrolled

Media Library

Insulin Degludec (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05362058 — Phase 3
Type 2 Diabetes Research Study Groups: Insulin Efsitora Alfa, Insulin Degludec
Type 2 Diabetes Clinical Trial 2023: Insulin Degludec Highlights & Side Effects. Trial Name: NCT05362058 — Phase 3
Insulin Degludec (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362058 — Phase 3
~309 spots leftby Jun 2025