Insulin Efsitora Alfa for Type 2 Diabetes

No longer recruiting at 182 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new insulin treatment, insulin efsitora alfa, for individuals with Type 2 diabetes who already use basal insulin. The study aims to determine if this new insulin is safe and effective compared to an existing insulin, insulin degludec. Participants will receive either the new insulin once a week or the existing insulin once a day for 78 weeks. The trial suits those managing Type 2 diabetes with basal insulin and currently taking at least 10 units of insulin daily. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin efsitora alfa is generally safe for people with type 2 diabetes. Studies have found it helps control blood sugar levels as effectively as other insulins, without causing concerning drops in blood sugar. No major safety issues have been reported so far. Administered once a week, this treatment might be more convenient than daily injections. Although still under testing, current evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 diabetes?

Insulin Efsitora Alfa is unique because it offers a once-weekly injection option for people with Type 2 diabetes, unlike most current treatments like insulin degludec, which require daily administration. This reduced frequency could greatly improve convenience and adherence to treatment for patients. Additionally, Insulin Efsitora Alfa's formulation at 500 units per milliliter is potent, potentially allowing for more efficient glucose control with fewer injections. Researchers are excited about these features because they could significantly enhance the quality of life for individuals managing Type 2 diabetes.

What evidence suggests that insulin efsitora alfa might be an effective treatment for Type 2 diabetes?

Research has shown that insulin efsitora alfa, which participants in this trial may receive, effectively manages Type 2 diabetes. This once-a-week insulin stabilizes blood sugar levels, similar to the daily insulin degludec, another treatment option in this trial. One study found that insulin efsitora alfa lowered A1C levels (a measure of long-term blood sugar control) by 0.86%, slightly better than the 0.75% reduction with degludec. Participants using insulin efsitora also spent more time with their blood sugar in the target range. Additionally, the study identified no major safety concerns, such as severe low blood sugar. ^{1 2 3 4 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. nejm.org nejm.org/doi/10.1056/NEJMoa2403953

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 ...

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05462756

NCT05462756 | A Study of Insulin Efsitora Alfa ... The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858722003886

Articles Safety and efficacy of once-weekly basal insulin Fc ... Weekly BIF treatment resulted in stable glycaemic control in people with type 2 diabetes previously treated with basal insulin. The reduced treatment burden of ...

5. investor.lilly.com investor.lilly.com/news-releases/news-release-details/first-its-kind-fixed-dose-study-once-weekly-insulin-efsitora

In a first-of-its-kind fixed dose study, once weekly insulin ... For the efficacy estimand7, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec resulting in an A1C of 6.93% and 7.03%, ...

6. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(22)00388-6/abstract

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.