Insulin Efsitora Alfa for Type 2 Diabetes

Recruiting at 153 trial locations

Overseen By Anna Chang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Basal insulin

Must not be taking: Prandial insulin

Disqualifiers: Type 1 diabetes, Liver disease, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 78 weeks

986 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you need to stop your current medications. However, you must be on a stable dose of your current insulin regimen and any acceptable non-insulin glucose-lowering therapies throughout the study.

What data supports the effectiveness of the drug Insulin Efsitora Alfa for Type 2 Diabetes?

Research shows that Insulin Efsitora Alfa, also known as Basal Insulin Fc, provides similar blood sugar control to daily Insulin Degludec in people with Type 2 Diabetes, allowing for once-weekly administration instead of daily injections. ^{1 2 3 4 5}

Is Insulin Efsitora Alfa safe for humans?

Research shows that Insulin Efsitora Alfa (also known as Basal Insulin Fc or LY3209590) has a safety profile comparable to Insulin Degludec in both type 1 and type 2 diabetes patients, indicating it is generally safe for human use. ^{1 3 4 6 7}

How is the drug Insulin Efsitora Alfa different from other diabetes treatments?

Insulin Efsitora Alfa is unique because it is designed for once-weekly administration, unlike most other insulin treatments that require daily injections. This drug combines a novel insulin variant with a human antibody component, potentially improving patient adherence and quality of life by reducing the frequency of injections. ^{1 3 4 8 9}

What is the purpose of this trial?

This trial is testing a new insulin drug called insulin efsitora alfa to see if it is safe and effective for people with Type 2 diabetes who are already using basal insulin. The study aims to help better control blood sugar levels over several months.

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 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.

Inclusion Criteria

Your body mass index (BMI) is 45 or less.

I take U100 or U300 insulin glargine daily.

I am taking metformin.

Exclusion Criteria

Are pregnant

Your kidney function is very low, less than 20 milliliters per minute per 1.73 square meters.

I have had significant weight changes in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive either insulin efsitora alfa or insulin degludec for glycemic control

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Treatment Details

Interventions

• Insulin Degludec
• Insulin Efsitora Alfa
• LY3209590

Trial Overview 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.

Participant Groups

Group I: 500 U/mL - Insulin Efsitora Experimental Treatment 1 Intervention

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Group II: 100 U/mL - Insulin Degludec Active Control 1 Intervention

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

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 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 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]

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]

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]

References

1. 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]

2. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. [2023]

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

In type 1 diabetes, weekly basal insulin Fc was noninferior to daily insulin degludec for HbA1c at 26 wk. [2023]

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

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes. [2022]

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

Single-dose pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 in healthy subjects. [2018]

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

Preclinical Characterization of LY3209590, a Novel Weekly Basal Insulin Fc-Fusion Protein. [2022]