22 Participants Needed

LY3209590 for Type 2 Diabetes in Children

Recruiting at 14 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3209590 (Insulin efsitora alfa) for children with Type 2 Diabetes to determine its absorption into the bloodstream and duration in the body. Researchers aim to understand how the body processes this medication after a single dose. Children who have had Type 2 Diabetes for at least 3 months, are not on insulin, and have stable blood sugar levels might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have used insulin for at least 3 months before the study. If you are on insulin, you would need to stop it before joining the trial.

Is there any evidence suggesting that LY3209590 is likely to be safe for humans?

Research has shown that LY3209590, also known as insulin efsitora alfa, has been tested for safety in people with type 2 diabetes. Recent studies found that this treatment is generally well-tolerated. For instance, one study compared LY3209590 to insulin degludec, and both showed similar safety results. Another study found that LY3209590 had a safety profile comparable to daily insulin, meaning it didn't cause more side effects than usual insulin treatments.

These findings suggest that LY3209590 is generally safe and doesn't cause unexpected issues. However, since this research is still in the early stages, it's important to note that scientists are still learning about how the treatment works in children with type 2 diabetes. Always consult a healthcare provider about potential risks and benefits before joining any clinical trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 2 diabetes in children, which often include oral medications and insulin injections, LY3209590 offers a new approach by being administered subcutaneously. This experimental treatment is a novel insulin receptor agonist, which means it works by directly targeting and activating insulin receptors, potentially leading to more efficient blood sugar control. Researchers are excited about LY3209590 because it may provide a more streamlined and effective method to manage diabetes, possibly reducing the frequency of doses and simplifying the treatment process for young patients.

What evidence suggests that LY3209590 might be an effective treatment for Type 2 Diabetes?

Research has shown that LY3209590, also known as insulin efsitora alfa, holds promise for managing diabetes. In earlier studies, it effectively controlled blood sugar in people with type 2 diabetes, similar to insulin degludec, a common insulin treatment. Specifically, those using LY3209590 maintained their blood sugar in the target range 64.3% of the time, compared to 61.2% for those using degludec. This suggests that LY3209590 can be a good option for managing blood sugar levels in people with type 2 diabetes. Additionally, the treatment did not show any serious safety concerns, such as severe low blood sugar episodes. Participants in this trial will receive LY3209590 administered subcutaneously.12367

Who Is on the Research Team?

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This clinical trial is for children and teenagers who have Type 2 Diabetes Mellitus. Participants will be involved in the study for about 100 days to see how their bodies handle a single dose of a new diabetes medication, LY3209590.

Inclusion Criteria

I have had Type 2 Diabetes for at least 3 months.
Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening
Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²)
See 1 more

Exclusion Criteria

Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product
I have had kidney problems in the past.
I am taking or have taken steroid medication.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of LY3209590

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after the single dose

96 days

What Are the Treatments Tested in This Trial?

Interventions

  • LY3209590
Trial Overview The trial is testing LY3209590, which is being studied to understand how much enters the bloodstream and how quickly it's eliminated from the body after one dose in young patients with Type 2 Diabetes.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: LY3209590Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

LY2963016 insulin glargine (Abasaglar/Basaglar) has been shown to be structurally and functionally similar to reference insulin glargine (Lantus), demonstrating equivalent efficacy in glycaemic control for both type 1 and type 2 diabetes patients in phase III ELEMENT trials.
The safety profile of LY insulin glargine is comparable to that of reference insulin glargine, with no additional safety concerns, making it a well-tolerated option for diabetes management, potentially at a lower cost.
LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes.Lamb, YN., Syed, YY.[2018]
LY2605541, a long-acting basal insulin analogue, shows consistent pharmacokinetics across various levels of renal function, indicating that its clearance is independent of renal impairment, which is important for patient safety.
The drug was well tolerated in both healthy individuals and those with renal impairment, and no dose adjustments are necessary for patients with renal issues or those undergoing hemodialysis.
Pharmacokinetics of the Long-Acting Basal Insulin LY2605541 in Subjects With Varying Degrees of Renal Function.Linnebjerg, H., Choi, SL., Lam, EC., et al.[2018]
In a 26-week phase 2 study involving 265 patients with type 1 diabetes, Basal Insulin Fc (BIF) showed noninferior glycemic control compared to daily degludec, with a slight treatment difference of 0.17% in HbA1c favoring degludec.
Both BIF and degludec had similar rates of hypoglycemia and serious adverse events, indicating that BIF is a safe alternative for once-weekly insulin administration.
Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes.Kazda, CM., Bue-Valleskey, JM., Chien, J., et al.[2023]

Citations

A Study of Insulin Efsitora Alfa (LY3209590) Compared ...The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with ...
Articles Safety and efficacy of once-weekly basal insulin Fc ...In this study, we explored the safety and efficacy of BIF in people with type 2 diabetes who had been previously treated with basal insulin.
Once-weekly insulin efsitora alfa versus ...This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes.
Insulin Efsitora versus Degludec in Type 2 Diabetes ...The percentage of time that the glucose level was within the target range was 64.3% with efsitora and 61.2% with degludec (estimated treatment ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36944059/
Once-Weekly Basal Insulin Fc Demonstrated Similar ...Conclusions: Once-weekly BIF achieved excellent glycemic control similar to degludec, with no concerning hypoglycemia or other safety findings.
Safety and efficacy of once-weekly basal insulin Fc in ...In this study, we explored the safety and efficacy of BIF in people with type 2 diabetes who had been previously treated with basal insulin.
Lilly's once-weekly insulin efsitora alfa demonstrated A1C ...In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora ...
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