Semaglutide for Type 1 Diabetes

(T1-DISCO Trial)

Recruiting at 1 trial location

Overseen By Kristen Nadeau, MD, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Colorado, Denver

Must be taking: Insulin

Must not be taking: Atypical antipsychotics, Steroids

Disqualifiers: Thyroid disease, Hypertension, Cancer, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semaglutide can improve heart and kidney health and enhance insulin response in people with type 1 diabetes. Already used for type 2 diabetes, semaglutide is being tested for its effectiveness in type 1 diabetes. Participants will receive either the medication or a placebo (a harmless pill with no treatment) through weekly injections. This trial may suit individuals with type 1 diabetes who use an insulin pump and have stable kidney function. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants the opportunity to contribute to a significant advancement in diabetes treatment.

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 requires stable doses of drugs that affect heart and kidney function. You cannot participate if you've used non-insulin diabetes medications or certain other drugs in the past 3 months.

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

Research has shown that semaglutide is usually well-tolerated by people with diabetes. In one study, only about 5.1% of patients stopped using the drug due to side effects. Serious side effects were rare, occurring in just 0.5% of cases. Another study found that semaglutide reduced the risk of heart problems in people with diabetes, indicating a positive safety profile.

Although semaglutide is not yet approved for type 1 diabetes, it has been used successfully in type 2 diabetes and obesity. This trial aims to assess its safety and effectiveness for people with type 1 diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Researchers are excited about semaglutide for Type 1 diabetes because it offers a potentially groundbreaking approach to managing the condition. Unlike standard insulin therapies, which focus on replacing insulin that the body can't produce, semaglutide is a GLP-1 receptor agonist that may help regulate blood sugar by enhancing insulin secretion and reducing appetite. This dual action could not only improve blood sugar control but also assist in weight management, a significant concern for many with diabetes. The convenience of weekly injections compared to daily insulin shots is another promising aspect, potentially improving adherence and quality of life for patients.

What evidence suggests that semaglutide might be an effective treatment for type 1 diabetes?

Research has shown that semaglutide, which participants in this trial may receive, may benefit people with type 1 diabetes and obesity. In one study, 36% of patients taking semaglutide achieved their main health goals, while none of the patients taking a placebo did. Semaglutide lowers the risk of heart problems in people with diabetes and helps reduce body weight and improve blood sugar levels. These benefits have been observed in both type 1 and type 2 diabetes, although semaglutide is not yet approved for use in type 1 diabetes. ^{3 4 5 6 7}

Who Is on the Research Team?

Petter Bjornstad, MD

Principal Investigator

University of Colorado, Denver

Kristen J Nadeau, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Adults aged 18-49 with type 1 diabetes for less than 30 years, a BMI of 20-35, and stable heart and kidney function can join. They must use insulin pumps or similar systems and effective birth control if female. Excluded are those with very high blood sugar levels, recent severe diabetes complications, certain hereditary diseases or pancreatitis history, other diabetes medication use in the last three months, shellfish/iodine allergy affecting specific tests, uncontrolled thyroid disease or hypertension.

Inclusion Criteria

I am on a stable dose of medication for heart or kidney health.

I am under 30 and have Type 1 Diabetes with antibodies.

You are using an insulin pump or automated insulin delivery system.

Exclusion Criteria

I or my family have a history of thyroid cancer, MEN2, or pancreatitis.

My thyroid condition or blood pressure is not under control despite treatment.

My HbA1c is above 9%, or I've recently had diabetic ketoacidosis or been hospitalized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo injections to assess effects on cardiovascular and kidney function

7 months

Weekly injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The trial is testing Semaglutide's impact on heart health and kidney function in adults with type 1 diabetes by comparing it to a placebo. Semaglutide has shown benefits for people with type 2 diabetes but isn't FDA-approved for type 1. Participants will be randomly assigned to receive either the drug via pen injector or a placebo.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks. Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks. Participants will receive 1.0 mg once weekly semaglutide injection for 6 months.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.

Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. Miyasaka, K.[2022]

In a meta-analysis of 23 randomized trials involving 22,096 patients with type 2 diabetes, semaglutide was not found to significantly increase the overall risk of diabetic retinopathy (DR) compared to control groups.

However, the analysis indicated that semaglutide was associated with a higher risk of DR in specific subgroups, particularly in patients aged 60 years or older and those with a diabetes duration of 10 years or more, suggesting that caution is warranted in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Wang, F., Mao, Y., Wang, H., et al.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40550013/

Semaglutide in Adults with Type 1 Diabetes and Obesity Results: A significantly greater percentage of patients in the semaglutide group than in the placebo group achieved the primary composite outcome (36% vs. 0%; ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/1733-P/159240/1733-P-Two-Year-Real-World-Effectiveness-of

Two-Year Real-World Effectiveness of Semaglutide in Patients ... Body weight reductions of ≥5%, ≥10%, ≥15%, and ≥20% from baseline at 2 years were observed in 90.5%, 69.8%, 46.9%, and 29.6% of patients, ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes.

4. nature.com nature.com/articles/s41591-024-03463-z

Subcutaneous weekly semaglutide with automated insulin ... Semaglutide has demonstrated glycemic, weight and cardiac benefits in those with and without type 2 diabetes (T2D). Although semaglutide has not ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149291824003308

Review Real-world Evidence on Oral Semaglutide for the ... Overall, oral semaglutide demonstrated a significant BW reduction of around 3 kg over 6 to 12 months of follow-up when administered in routine clinical practice ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39118222/

Real-world safety profile of once-weekly semaglutide in ... In total, 5.1% of patients reported AEs that led to treatment discontinuation, 0.5% reported serious adverse drug reactions and 0.2% had an AE ...

7. breakthrought1d.org breakthrought1d.org/grants/united-states/colorado/efficacy-and-safety-of-once-weekly-semaglutide-in-adults-with-obesity-and-inadequately-controlled-type-1-diabetes-using-hybrid-closed-loop-system/

EFFICACY AND SAFETY OF ONCE WEEKLY ... Considering the data from the above studies, we expect that 30-40% adults with T1D using HCL and randomized to semaglutide will achieve the composite outcome ...