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Insulin
Weekly Basal Insulin for Type 2 Diabetes (QWINT-4 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 been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
once daily U-100 or U-200 insulin degludec
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 22 to week 26
Awards & highlights
QWINT-4 Trial Summary
This trial will compare the efficacy and safety of a new once-weekly diabetes medication with daily insulin glargine in people with type 2 diabetes.
Who is the study for?
Adults with Type 2 diabetes who are already on a stable regimen of basal insulin and at least two daily prandial insulin injections, have an HbA1c level between 7.0% to 10%, and a BMI ≤45 kg/m² can join this trial. They must not plan to change their glucose monitoring or have had severe hypoglycemia or ketoacidosis recently.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Insulin Efsitora Alfa (LY3209590), taken once weekly, against daily Insulin Glargine in people with Type 2 diabetes over a period up to 34 weeks, including screening, treatment, and follow-up phases.See study design
What are the potential side effects?
Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at the injection site, weight gain, swelling in arms or legs, and possible changes in potassium levels which could cause heart rhythm problems.
QWINT-4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable insulin regimen for at least 90 days.
Select...
I am taking U-100 or U-200 insulin degludec daily.
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I use U-100 or U-300 insulin glargine daily.
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I use U-100 insulin detemir or NPH insulin once or twice daily.
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I have been using insulin at least twice a day for over 90 days, including before dinner.
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I have type 2 diabetes, use basal insulin, and take prandial insulin injections twice daily.
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I am taking 10 or more units of basal insulin daily.
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I take 2 or fewer units of insulin per kilogram of my body weight daily.
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I have been on a stable insulin regimen for at least 3 months.
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I've been taking insulin at least twice a day for 3 months, including with my evening meal.
QWINT-4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 22 to week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 22 to week 26
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 HbA1c
Secondary outcome measures
Basal Insulin Dose
Basal Insulin Dose to Total Insulin Dose Ratio
Bolus Insulin Dose
+11 moreQWINT-4 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Efsitora Alfa + Insulin LisproExperimental Treatment2 Interventions
Participants will be given insulin efsitora alfa by subcutaneous (SC) injection along with insulin lispro
Group II: Insulin Glargine + Insulin LisproActive Control2 Interventions
Participants will be given insulin glargine by SC injection along with insulin lispro
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Efsitora Alfa
2022
Completed Phase 3
~730
Insulin Lispro (U100)
2020
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,199 Total Patients Enrolled
Study DirectorEli Lilly and Company
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh less than a certain amount based on your height.I use U-100 insulin detemir or NPH insulin once or twice daily.I have been using insulin at least twice a day for over 90 days, including before dinner.I've been taking insulin at least twice a day for 3 months, including with my evening meal.I have been on a stable dose of my diabetes medication for at least 90 days.I plan to change my personal glucose monitoring method during the study.I have had severe low blood sugar episodes in the last 6 months.I am taking 10 or more units of basal insulin daily.I've been hospitalized more than once for severe ketoacidosis or coma in the last 6 months.The doctor thinks you cannot tell when your blood sugar is too low.I have type 1 diabetes, latent autoimmune diabetes, or another specific type not including type 2.I had weight loss surgery within the last year.I have type 2 diabetes, use basal insulin, and take prandial insulin injections twice daily.Your HbA1c value is between 7.0% and 10%.I have been on a stable insulin regimen for at least 3 months.I use U-100 or U-300 insulin glargine daily.I take 2 or fewer units of insulin per kilogram of my body weight daily.I have not had severe heart failure or major heart conditions in the last 3 months.I have been on insulin therapy in the last 90 days.I have been on a stable insulin regimen for at least 90 days.I am taking U-100 or U-200 insulin degludec daily.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Efsitora Alfa + Insulin Lispro
- Group 2: Insulin Glargine + Insulin Lispro
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled slots in this test that new patients could take part in?
"Although the original posting was on 8/11/2022, this clinical trial mentioned on clinicaltrials.gov is still actively recruiting patients."
Answered by AI
Are there any negative side effects of LY3209590?
"LY3209590 has been given a safety score of 3 by our analysts at Power. This is due to the fact that LY3209590 is currently in Phase 3 clinical trials, which means that there is efficacy data as well as multiple rounds of safety data available."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Thomas Jefferson University - Clinical Research Institute
Thomas Jefferson University Hospital
Why did patients apply to this trial?
Because I’m interested in learning more about type 2 diabetes.
PatientReceived no prior treatments
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