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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
Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
Antibody + Type 1 Diabetes (T1D) <30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 8
Awards & highlights

T1-DISCO Trial Summary

This trial will assess the effects of semaglutide, a medication not approved by the FDA, on people with type 1 diabetes. It may reduce CV disease and kidney disease and improve glucose control and BMI.

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.Check my eligibility
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.See study design
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.

T1-DISCO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable dose of medication for heart or kidney health.
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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.

T1-DISCO Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Insulin Sensitivity
Change in Renal Vascular Resistance (RVR)

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
26%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Upper respiratory tract inflammation
3%
Back pain
2%
Vomiting
2%
Diarrhoea
2%
Abdominal discomfort
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

T1-DISCO 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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,632 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,818 Previous Clinical Trials
47,295,237 Total Patients Enrolled
Petter M Bjornstad, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05819138 — Phase 3
Type 1 Diabetes Research Study Groups: Placebo, Semaglutide
Type 1 Diabetes Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05819138 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05819138 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been observed with the use of Semaglutide?

"We at Power rate Semaglutide's safety a 3, given that Phase 3 trials imply the existence of positive efficacy data and multiple layers of evidence for its security."

Answered by AI

Does this research experiment have any age restrictions?

"Those eligible to be enrolled in this trial must fit the age criteria of 18-40. There are 223 trials targeting minors and 946 that exclusively focus on adults over 65 years old."

Answered by AI

Could I participate in this experiment?

"60 participants aged 18-40 with type 1 diabetes will be admitted to this trial. Additional criteria include having a BMI between 20 and 35 kg/m2, plus the use of insulin pump or automated insulin delivery systems."

Answered by AI

Is this exploration still recruiting participants?

"According to clinicaltrials.gov, this medical trial is not actively recruiting any participants at the moment; it was initially published on June 1st 2023 and last edited on April 4th 2023. However, there are still 1287 other trials that require enrolment right now."

Answered by AI
~40 spots leftby Oct 2026