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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 belowSelect...
I have been diagnosed with Type 2 Diabetes.
Select...
I have been on a stable diabetes medication for at least 3 months.
QWINT-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 to 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 EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Change from Baseline in Fasting Glucose
+8 moreQWINT-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
~730
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,001 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,324 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Type 2 Diabetes.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.Your HbA1c level is between 7.0% and 10% at the time of screening.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.I have a blood disorder that affects my hemoglobin levels.I have not had severe heart failure or major heart-related issues in the last 3 months.I had weight loss surgery less than a year ago.I've been hospitalized for ketoacidosis or coma more than once in the last 6 months.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers looking for more people to participate in this experiment?
"From what is published on clinicaltrials.gov, it seems that this particular clinical trial is still looking for participants. The first posting was on 6/3/2022 and the most recent update was on 11/9/2022."
Answered by AI
What are the potential risks associated with LY3209590?
"LY3209590 has been given a safety score of 3 by our analysts at Power. This is due to the fact that LY3209590 is in Phase 3 trials, meaning there is both efficacy and safety data available."
Answered by AI
How many different individuals are included in this clinical trial?
"In order to begin this study, 912 individuals who fit the pre-determined inclusion criteria must enroll. Potential participants can visit sites such as Qualmedica Research, LLC in Evansville, Indiana and SKY Clinical Research Network Group-Quinn in Ridgeland, Mississippi."
Answered by AI
At how many different research facilities can people participate in this trial?
"Qualmedica Research, LLC in Evansville, Indiana is the primary location for this study. However, research is also being conducted at SKY Clinical Research Network Group-Quinn in Ridgeland, Mississippi and Alliance for Multispecialty Research as well as 47 additional medical centres."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Ontario
California
How old are they?
18 - 65
What site did they apply to?
NorCal Medical Research, Inc
Catalina Research Institute, LLC
Southern California Dermatology, Inc.
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
During my 24 year journey as a T2 I have always been looking for a better process to care for my diabetes. Being insulin Resistant makes my life different than other diabetics.
PatientReceived 1 prior treatment
Honestly im on Ozempic .25 and farxiga 10 mg for diabetes only my sugars are not where they should be, they stay at 197 basically when i sleep and 135-150 when i wake and i want to be well controlled.
PatientReceived 2+ prior treatments
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