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Insulin
Insulin Efsitora Alfa vs. Insulin Glargine for Type 2 Diabetes (QWINT-1 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
Are insulin naive
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 52
Awards & highlights
QWINT-1 Trial Summary
This trial will test the safety and effectiveness of a new type 2 diabetes medication vs. insulin glargine.
Who is the study for?
This trial is for adults with Type 2 Diabetes who are starting basal insulin therapy for the first time. They should have an HbA1c level between 7.0% to 10.0%, be on a stable diabetes medication regimen, and not have used insulin except briefly or for gestational diabetes. People with recent severe diabetes complications, certain heart conditions, other types of diabetes, or those who've had specific surgeries or significant weight changes recently cannot join.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of a new weekly insulin called Insulin Efsitora Alfa (LY3209590) compared to daily Insulin Glargine in people newly starting on long-acting insulin treatments for Type 2 Diabetes.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 and legs, and possible systemic allergic reactions.
QWINT-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never used insulin.
Select...
I have been on a stable diabetes medication for at least 3 months and can continue it during the study.
Select...
I have been diagnosed with Type 2 Diabetes.
QWINT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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 Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction
Change from Baseline in Fasting Glucose
+6 moreQWINT-1 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 GlargineActive Control1 Intervention
Participants will receive insulin glargine SC once daily.
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
3,200,262 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,456 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have only used insulin short-term or for gestational diabetes.I have not had severe heart failure or major heart-related issues in the last 3 months.I have never used insulin.My weight has changed by more than 5% in the last 3 months.I have been on a stable diabetes medication for at least 3 months and can continue it during the study.I have been diagnosed with a type of diabetes that is not type 2.I have a blood disorder that affects my hemoglobin levels.I had weight loss surgery less than a year ago.You have had very low blood sugar episodes within the last 6 months.I have been diagnosed with Type 2 Diabetes.I was hospitalized for ketoacidosis or coma more than once in the last 6 months.Your HbA1c level is between 7.0% and 10.0% during screening.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Efsitora Alfa
- Group 2: Insulin Glargine
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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05662332 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any regulatory bodies granted authorization for LY3209590?
"Our team at Power rates the safety of LY3209590 a 3 on the scale due to this being a Phase 3 trial, with both evidence backing its efficacy and multiple verifications confirming its security."
Answered by AI
How many distinct sites are overseeing this clinical trial?
"Syed Research Consultants Llc in Sheffield, AMCR Institute in Escondido and Velocity Clinical Research, Gardena in Gardena are just three of the 40 sites currently partaking in this medical study."
Answered by AI
Are new participants currently being accepted for this research study?
"At present, clinicaltrials.gov signals that recruitment for this study has concluded. This trial was first posted on January 16th 2023 and last updated on December 21st 2022, however there are still 1474 other trials recruiting patients at the current moment in time."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Texas
Missouri
What site did they apply to?
AMCR Institute
Velocity Clinical Research, Gardena
Endocrine Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To help others and myself. Getting my blood under control and possibly getting paid.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is this trial?
PatientReceived no prior treatments
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