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Insulin
Insulin Efsitora Alfa vs. Insulin Degludec for Type 1 Diabetes (QWINT-5 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 received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 22 to week 26
Awards & highlights
QWINT-5 Trial Summary
This trial is testing a new diabetes medication against insulin degludec to see if it is more effective and has fewer side effects.
Who is the study for?
This trial is for people with type 1 diabetes who have been diagnosed for at least a year, have an HbA1c level between 7.0% to 10.0%, and a BMI of ≤35 kg/m². They must be on basal-bolus insulin injection therapy for over 90 days. It's not open to those with type 2 diabetes or other specific types, nor anyone who had severe hypoglycemia or diabetic ketoacidosis requiring hospitalization more than once in the past six months.Check my eligibility
What is being tested?
The study compares Insulin Efsitora Alfa (LY3209590) with Insulin Degludec in managing blood sugar levels in participants using multiple daily injections as their treatment method for type 1 diabetes.See study design
What are the potential side effects?
Potential side effects may include low blood sugar episodes (hypoglycemia), allergic reactions at the injection site, weight gain, swelling of arms and legs, and possible disruption of body's normal response to low blood sugar.
QWINT-5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a specific insulin treatment plan for over 90 days.
QWINT-5 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
Glycosylated hemoglobin A
Secondary outcome measures
Basal Insulin Dose
Bolus Insulin Dose
Change from Baseline in Body Weight
+10 moreQWINT-5 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Efsitora AlfaExperimental Treatment1 Intervention
Participants will receive insulin efsitora alfa by subcutaneously (SC)
Group II: Insulin DegludecActive Control1 Intervention
Participants will receive insulin degludec SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Efsitora Alfa
2022
Completed Phase 3
~730
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,366 Total Patients Enrolled
10 Trials studying Diabetes
14,927 Patients Enrolled for Diabetes
Study ChairEli Lilly and Company
5 Previous Clinical Trials
560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with type 2 diabetes or a specific type other than type 1.I have had more than one severe low blood sugar episode in the last 6 months.I have been on a specific insulin treatment plan for over 90 days.I've been hospitalized more than once for severe diabetes complications in the last 6 months.You weigh less than a certain amount for your height.Your HbA1c level is between 7.0% and 10.0%.I have been diagnosed with type 1 diabetes for over a year.Your HbA1c level is between 7.0% and 10.0% as determined by the central laboratory at screening.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Efsitora Alfa
- Group 2: Insulin Degludec
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.
Diabetes Patient Testimony for trial: Trial Name: NCT05463744 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is LY3209590's status in terms of federal approval?
"LY3209590 has received a safety score of 3. This is because, as a Phase 3 trial medication, there is both some evidence of its efficacy and multiple rounds of data supporting its safety."
Answered by AI
How many test subjects are included in the sample size for this research project?
"The clinicaltrials.gov website shows that this research is looking for new participants. The first posting was on 8/12/2022, with the latest update on 11/3/2022. There are 35 centres across the country recruiting a total of 670 individuals."
Answered by AI
Are there any patients who can still enroll in this clinical trial?
"The listed clinical trial on clinicaltrials.gov is currently recruiting patients, with the study having been posted on 8/12/2022 and last updated on 11/3/2022."
Answered by AI
How many different offices are coordinating this clinical trial today?
"There are a total of 38 research sites for this study. The three primary locations are Dallas Diabetes Research Center in Dallas, New york, Research Institute of Dallas in Syracuse, Florida, and SUNY Upstate Medical University in Austin, Kansas with 35 other centers supporting these efforts."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
California
What site did they apply to?
Catalina Research Institute, LLC
Palm Research Center Tenaya
Thomas Jefferson University - Clinical Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
Tried 2 medications. I would like to know more about diabetes.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Any payment for the study?
PatientReceived no prior treatments
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