Semaglutide for Type 1 Diabetes

(T1-DISCO Trial)

Recruiting at 1 trial location

Overseen By Kristen Nadeau, MD, MS

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing semaglutide, a drug that helps with heart, kidney, and blood sugar health, in adults with type 1 diabetes. The drug has shown benefits for people with type 2 diabetes, but it is not yet approved for type 1 diabetes. Researchers want to see if it can provide similar health improvements for this new group. Semaglutide has been evaluated in numerous trials for its effectiveness in improving blood sugar levels and weight loss in type 2 diabetes.

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.

What data supports the effectiveness of the drug Semaglutide for Type 1 Diabetes?

Semaglutide has been shown to effectively lower blood sugar levels and body weight in patients with type 2 diabetes, which suggests it might have potential benefits for managing blood sugar in type 1 diabetes as well. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide, used in treatments like Rybelsus and Ozempic, has been shown to be generally safe in humans, with its safety profile consistent with other similar medications. It has been tested in people with type 2 diabetes and found to be safe for the heart, with common side effects including gastrointestinal issues like nausea. ^{1 2 3 5 6}

How is the drug Semaglutide unique for treating Type 1 Diabetes?

Semaglutide is unique because it is a GLP-1 receptor agonist, originally used for Type 2 Diabetes, that helps lower blood sugar by stimulating insulin release and also aids in weight loss. It is administered once weekly via injection or can be taken orally, which is different from the daily insulin injections typically used in Type 1 Diabetes management. ^{2 3 4 5 7}

Research Team

Petter Bjornstad, MD

Principal Investigator

University of Colorado, Denver

Kristen J Nadeau, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

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

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Semaglutide (Glucagon-like peptide-1 receptor agonist)

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.

Participant Groups

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 Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

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+

Findings from Research

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]

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, 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]

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]

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]

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]

References

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

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]

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

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

3. Japan pubmed.ncbi.nlm.nih.gov

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

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

Semaglutide: First Global Approval. [2019]

5. Belgium pubmed.ncbi.nlm.nih.gov

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

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

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

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

Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. [2022]