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Insulin
Insulin Efsitora Alfa for Type 2 Diabetes
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
once daily U100 or U300 of insulin glargine
once daily U100 or U200 of insulin degludec
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 22 to week 26
Awards & highlights
Study Summary
This trial is to see if LY3209590 is a safe and effective treatment for Type 2 diabetes in patients who are already taking basal insulin. The study will last up to 86 weeks and will involve a 3-week screening period, a 78-week treatment period, and a 5-week safety follow-up period.
Who is the study for?
This trial is for adults with Type 2 diabetes who are already using basal insulin. They should be taking a stable dose of certain insulins, have a BMI of 45 kg/m² or less, and an HbA1c level between 6.5% - 10%. People with untreated cancer, recent bariatric surgery, severe liver disease (except NAFLD), pregnancy, Type 1 diabetes, significant weight changes in the last three months or specific heart conditions can't join.Check my eligibility
What is being tested?
The study tests if Insulin Efsitora Alfa (LY3209590) is as safe and effective as Insulin Degludec in people with Type 2 diabetes currently treated with basal insulin. The trial includes screening, treatment for over a year and follows up to check safety after stopping the drug.See study design
What are the potential side effects?
Potential side effects may include low blood sugar levels (hypoglycemia), allergic reactions at injection sites like redness or swelling, weight gain due to insulin use, and possibly other unknown risks associated with new drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I take U100 or U300 insulin glargine daily.
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I am taking U100 or U200 insulin degludec daily.
Select...
I use insulin detemir or NPH insulin once or twice daily.
Select...
I am not taking DPP-4 inhibitors for diabetes.
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I have Type 2 diabetes and am treated with basal insulin.
Select...
I take between 10 and 110 units of basal insulin daily.
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 Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ)
Change from Baseline in Fasting Glucose
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Efsitora AlfaExperimental Treatment1 Intervention
Participants will be given insulin efsitora alfa subcutaneously (SC).
Group II: Insulin DegludecActive Control1 Intervention
Participants with be given 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
2,613 Previous Clinical Trials
3,199,943 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is 45 or less.I take U100 or U300 insulin glargine daily.I am taking metformin.Your kidney function is very low, less than 20 milliliters per minute per 1.73 square meters.I am taking U100 or U200 insulin degludec daily.I have had significant weight changes in the last 3 months.Your HbA1c value is between 6.5% and 10% at the screening.I had weight loss surgery less than a year ago.I use insulin detemir or NPH insulin once or twice daily.I do not have liver disease, except for NAFLD.You have Type 1 diabetes.I am taking medication for diabetes that includes SGLT2 inhibitors.I am taking up to 3 non-insulin medications for my diabetes.I've been on a stable insulin regimen for over 90 days.I have used specific insulin treatments in the past 6 months.I have not had severe heart failure or major heart-related issues in the last 3 months.I am not taking DPP-4 inhibitors for diabetes.I have cancer that is currently active or hasn't been treated.I have Type 2 diabetes and am treated with basal insulin.I take between 10 and 110 units of basal insulin daily.
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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05275400 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When might we see LY3209590 on the market as an approved medication?
"LY3209590 is considered safe according to our 3-point scale at Power. This is because LY3209590 is in Phase 3 trials, meaning that efficacy has been supported by some data and safety has been supported by multiple rounds of data."
Answered by AI
Could you tell me how many research institutions are participating in this investigation?
"There are 47 clinical trial sites that are actively recruiting patients, such as Gadolin Research in Beaumont, SKY Clinical Research Network Group - Hall in Fayette, and Palm Research Center Tenaya in Las Vegas."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Tennessee
Texas
How old are they?
18 - 65
What site did they apply to?
Diabetes Associates Medical Group
Coastal Metabolic Research Centre
HealthPartners Institute dba International Diabetes Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I’m interested in new treatment therapies for my type 2 diabetes. I am desperately trying to find better options to treat my diabetes. It has truly made me become disabled. I have severe neuropathy and it is damaging my quality of life.
PatientReceived no prior treatments
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