SAR442970 for Type 1 Diabetes

(T1D OBTAIN Trial)

Recruiting at 12 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Insulin

Must not be taking: Corticosteroids, Immunosuppressives, Biologics, others

Disqualifiers: Infections, Cancer, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

84 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as immunosuppressive therapies and specific diabetes treatments other than insulin, before and during the study. It's best to discuss your current medications with the study team to see if they are allowed.

What safety information is available for SAR442970 in humans?

The safety of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which are similar to SAR442970, has been studied in type 1 diabetes. These studies found that while they can cause mild and temporary stomach-related side effects, they generally do not increase the risk of low blood sugar when used with insulin. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of SAR442970 in comparison to placebo to preserve β-cell function in participants with recently diagnosed type 1 diabetes (T1D) on insulin therapy. The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into SAR442970 and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo). The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.

Eligibility Criteria

This trial is for individuals aged 12-35 with recently diagnosed type 1 diabetes who have started insulin therapy within the last 90 days. They must meet specific criteria set by the American Diabetes Association and have certain levels of C-peptide in their blood.

Inclusion Criteria

Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).

I started using insulin less than 90 days ago.

I am on insulin therapy.

Exclusion Criteria

I have had cancer before, but it was either skin cancer or early-stage cancer that was treated.

History of systemic hypersensitivity reaction or significant allergies to any humanized mAb.

Has other autoimmune or inflammatory conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 to 5 weeks

Treatment

Participants receive subcutaneous injections of SAR442970 or placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Treatment Details

Interventions

• SAR442970

Trial Overview The study tests SAR442970, a new medication aimed at preserving β-cell function in diabetics, against a placebo. Participants are randomly assigned to either the drug or placebo group, with three times more participants receiving SAR442970 than the placebo.

Participant Groups

Group I: SAR442970 Experimental Treatment 1 Intervention

Participants will receive subcutaneous injection of SAR442970.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive subcutaneous injection of matching placebo.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

This study will evaluate the effects of the GLP-1 analogue liraglutide on pancreatic β-cell function in young individuals (ages 10-30) with early stages of type 1 diabetes, including those with multiple islet autoantibodies, over a 6-month period with follow-ups ranging from 6 to 18 months.

Liraglutide aims to support β-cell health and potentially reduce islet autoimmunity, contrasting with most prevention trials that focus solely on the immune system, thus providing a novel approach to managing early type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Kero, J., Koskenniemi, JJ., Karsikas, S., et al.[2022]

GLP-1 receptor agonists (like exenatide and liraglutide) can significantly lower hemoglobin A1C levels, plasma glucose, and body weight in patients with type 1 diabetes who are already on insulin, without increasing the risk of hypoglycemia.

The most common side effects of GLP-1 RAs are mild and transient gastrointestinal issues, making them a safe option for patients struggling with insulin side effects or those needing to lose weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Role of Glucagon-Like Peptide-1 Receptor Agonists in the Management of Type 1 Diabetes Mellitus. Harris, KB., Boland, CL.[2022]

The review highlights a growing need for effective therapies for type 1 diabetes (T1D), as currently, insulin is the only approved treatment, and many new drugs are in clinical development, including those with established and novel mechanisms of action.

New drug classes under investigation include SGLT inhibitors, GLP-1 agonists, and immunomodulatory drugs, with many compounds currently in Phase 1 and 2 trials, indicating a promising future for combination therapies that could enhance treatment options for T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. Mittermayer, F., Caveney, E., De Oliveira, C., et al.[2018]

Type 1 diabetes is increasingly common, affecting about 1 in 300 people, and early intervention during the prediabetic phase, identified by islet autoantibodies, is crucial for potential prevention.

Current therapies, including monoclonal antibodies and immunosuppressants, have not yet achieved long-term remission or prevention of type 1 diabetes, highlighting the need for a balance between safety and efficacy in developing new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention strategies for type 1 diabetes mellitus: current status and future directions. Winter, WE., Schatz, D.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). [2022]

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

Adjunctive Role of Glucagon-Like Peptide-1 Receptor Agonists in the Management of Type 1 Diabetes Mellitus. [2022]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development. [2018]

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

Glucagon-like peptide 1 receptor agonists in type 1 diabetes mellitus. [2020]

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

Prevention strategies for type 1 diabetes mellitus: current status and future directions. [2018]