What is the mechanism of action of this treatment?

The most common treatment for Type 1 Diabetes is insulin therapy, which replaces the insulin that the pancreas cannot produce, thereby regulating blood glucose levels and preventing complications. GLP-1 receptor agonists, such as Semaglutide, are being studied for their potential benefits in Type 1 Diabetes. These agents enhance glucose-dependent insulin secretion, delay gastric emptying, and reduce food intake. This matters for Type 1 Diabetes patients as it offers the possibility of improved glycemic control and cardiovascular outcomes, providing a more comprehensive management strategy beyond traditional insulin therapy.

What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as Semaglutide, used in the treatment of Type 1 Diabetes, are associated with several side effects. Commonly reported adverse effects include gastrointestinal symptoms like nausea, vomiting, and diarrhea. There is also a potential risk for more serious conditions such as pancreatitis, gallbladder disease, and thyroid C-cell tumors. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 should avoid these medications. It is important to discuss these risks with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has not approved semaglutide or other GLP-1 receptor agonists specifically for the treatment of Type 1 Diabetes. Current FDA-approved treatments for Type 1 Diabetes primarily include insulin therapy and adjunctive treatments like pramlintide, an amylin analog. While semaglutide has shown efficacy in Type 2 Diabetes for improving glucose control and cardiovascular outcomes, its use in Type 1 Diabetes remains experimental and is currently being studied for potential benefits in this population.

What other types of research exist?

Promising alternatives to Semaglutide for Type 1 Diabetes patients include liraglutide and exenatide, which are GLP-1 receptor agonists approved for use in children and adolescents with T1DM. Additionally, pramlintide, an amylin analog, has shown potential as an adjunctive therapy to insulin. Metformin may also be considered for its benefits in weight management, although it does not improve glycemic control significantly.

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Glucagon-like peptide-1 receptor agonist

Semaglutide for Type 1 Diabetes (T1-DISCO Trial)

Phase 3

Recruiting

Led By Petter M Bjornstad, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Antibody + Type 1 Diabetes (T1D) <30 years

Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2

Must not have

History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis

Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 8

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include digestive issues like nausea or diarrhea; allergic reactions; low blood sugar when combined with insulin; increased heart rate; potential risk of thyroid tumors based on findings from animal studies (not proven in humans); inflammation of the pancreas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidney function, measured by eGFR, is at least 45.

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I am between 18 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have used diabetes or steroid medications in the last 3 months.

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I have a serious illness like cancer.

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I am taking medication for mental health that is not a typical antipsychotic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Ascending Aortic Pulse Wave Velocity (AA PWV)

Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)

Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)

Secondary study objectives

Change in Insulin Sensitivity

Change in Renal Vascular Resistance (RVR)

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 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: PlaceboPlacebo Group1 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Type 1 Diabetes is insulin therapy, which replaces the insulin that the pancreas cannot produce, thereby regulating blood glucose levels and preventing complications. GLP-1 receptor agonists, such as Semaglutide, are being studied for their potential benefits in Type 1 Diabetes. These agents enhance glucose-dependent insulin secretion, delay gastric emptying, and reduce food intake. This matters for Type 1 Diabetes patients as it offers the possibility of improved glycemic control and cardiovascular outcomes, providing a more comprehensive management strategy beyond traditional insulin therapy.