LY3209590 for Type 2 Diabetes in Children

Recruiting at 13 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Glucocorticoids

Disqualifiers: Severe hypoglycemia, Renal impairment, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

22 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.

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 LY3209590 (Insulin efsitora alfa) safe for use in humans?

LY3209590, also known as Insulin efsitora alfa or Basal Insulin-FC, has been studied in people with type 1 and type 2 diabetes and showed a safety profile similar to other insulins like insulin degludec, meaning it was generally well-tolerated in these studies. ^{1 2 3 4 5}

What makes the drug LY3209590 unique for treating type 2 diabetes in children?

LY3209590, also known as insulin efsitora alfa, is unique because it is designed for once-weekly administration, unlike most other insulins that require daily injections. This drug combines a novel insulin variant with a human protein component, potentially offering more convenience and improved adherence for patients. ^{1 2 5 6 7}

What data supports the effectiveness of the drug LY3209590 for Type 2 Diabetes in children?

Research shows that LY3209590, also known as Basal Insulin Fc, provides similar blood sugar control to another insulin called degludec in adults with Type 2 Diabetes, suggesting it could be effective in children as well. ^{1 2 8 9 10}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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)

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: LY3209590 Experimental Treatment 1 Intervention

LY3209590 administered subcutaneously (SC).

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

In a study involving 572 children and adolescents with type 1 diabetes over 26 weeks, insulin glulisine was found to be as effective as insulin lispro in managing blood sugar levels, with similar changes in hemoglobin A1c.

Both insulins had comparable safety profiles, with similar rates of hypoglycemia and adverse events, indicating that glulisine is a viable alternative to lispro in a basal-bolus insulin regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparable efficacy and safety of insulin glulisine and insulin lispro when given as part of a Basal-bolus insulin regimen in a 26-week trial in pediatric patients with type 1 diabetes. Philotheou, A., Arslanian, S., Blatniczky, L., et al.[2022]

In a study of 50 children and adolescents with poorly controlled type 1 diabetes, switching to the IDegAsp insulin co-formulation led to a significant reduction in self-reported mild to moderate hypoglycemic episodes after one year.

While the overall hemoglobin A1c levels remained unchanged, the frequency of diabetic ketoacidosis (DKA) attacks decreased from 11 to 4, suggesting that IDegAsp may enhance clinical management for patients struggling with frequent hypoglycemia and DKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients Kırkgöz, T., Eltan, M., Kaygusuz, SB., et al.[2022]

In a 26-week study involving 278 insulin-naive patients with type 2 diabetes, the once-weekly basal insulin Fc (BIF) showed noninferior effectiveness in lowering HbA1c levels compared to the daily insulin degludec, indicating it can be a viable alternative for insulin administration.

Both BIF and degludec had low rates of hypoglycemia, with no significant differences in safety profiles, suggesting that BIF is a safe option for managing blood sugar levels in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Bue-Valleskey, JM., Kazda, CM., Ma, C., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a 52-week trial involving 347 children and adolescents with Type 1 diabetes, insulin detemir was found to be non-inferior to NPH insulin in controlling blood sugar levels, as measured by HbA1c.

Insulin detemir significantly reduced the risk of hypoglycemic events and resulted in a decrease in weight standard deviation scores compared to NPH insulin, indicating a safer profile for managing diabetes in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Thalange, N., Bereket, A., Larsen, J., et al.[2022]

Insulin glargine 300 U/mL (Gla-300) provides glycemic control similar to that of the standard Gla-100, with a mean reduction in glycated hemoglobin A1c of -1.02% in a meta-analysis of over 2400 patients with type 1 and type 2 diabetes.

Gla-300 is associated with a lower risk of nocturnal hypoglycemia (relative risk of 0.75) and potentially less weight gain compared to Gla-100, making it a promising alternative for long-acting insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 Diabetes Mellitus. Goldman, J., White, JR.[2022]

Basal insulin Fc (BIF) demonstrated a long half-life of approximately 17 days, allowing for once-weekly dosing while effectively reducing fasting blood glucose levels for at least 5 days without severe hypoglycemia.

In a 6-week study involving 33 participants with type 2 diabetes, BIF showed a consistent glucose control profile similar to insulin glargine, indicating it is well tolerated and has a favorable pharmacokinetic and pharmacodynamic profile for further development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. Heise, T., Chien, J., Beals, JM., et al.[2023]

In Phase 2 trials involving 288 patients with type 2 diabetes and 137 with type 1 diabetes, the basal insulin analogue LY2605541 was associated with significant weight loss compared to insulin glargine, with 56.9% of T2DM and 66.1% of T1DM patients experiencing weight loss.

LY2605541 treatment led to a higher percentage of patients achieving ≥5% weight loss compared to glargine (4.8% vs. 0% in T2DM and 11.9% vs. 0.8% in T1DM), indicating its potential as a weight-neutral or weight-reducing insulin option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrasting weight changes with LY2605541, a novel long-acting insulin, and insulin glargine despite similar improved glycaemic control in T1DM and T2DM. Jacober, SJ., Rosenstock, J., Bergenstal, RM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes. Lamb, YN., Syed, YY.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparable efficacy and safety of insulin glulisine and insulin lispro when given as part of a Basal-bolus insulin regimen in a 26-week trial in pediatric patients with type 1 diabetes. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Efficacy of the Novel Degludec/Aspart Insulin Co-formulation in Children and Adolescents with Type 1 Diabetes: A Real-life Experience with One Year of IDegAsp Therapy in Poorly Controlled and Non-compliant Patients [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 Diabetes Mellitus. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Contrasting weight changes with LY2605541, a novel long-acting insulin, and insulin glargine despite similar improved glycaemic control in T1DM and T2DM. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of the Long-Acting Basal Insulin LY2605541 in Subjects With Varying Degrees of Renal Function. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

LY2963016 Insulin Glargine: A Review in Type 1 and 2 Diabetes. [2018]