Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Diabetes Mellitus, Type 1 Clinical Trial

— T1-DISCO  

Official title:

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819138
• Other study ID #: 22-0794
• Secondary ID: R01HL165433
• Status: Recruiting
• Phase: Phase 3
• Start date: June 21, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Kyla Best
• Phone: 720-777-9500
• Email: Kyla.Best[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Age 18-49 years

• 1) T1D diagnosis defined as diabetes <30 years duration plus positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis, <30 years duration

• Insulin pump or automated insulin delivery systems

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

• Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)

• BMI 20-45 kg/m2

• Adequate contraceptive method for females

Exclusion Criteria:

• HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization

• Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy

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

• Current/planned pregnancy or nursing

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

• Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months

• Use of atypical antipsychotics

• Significant systemic illness such as cancer

• Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)

• MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Semaglutide Pen Injector
Semaglutide injection
• Placebo
Semaglutide placebo injection

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ascending Aortic Pulse Wave Velocity (AA PWV)	AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.	Baseline, month 8
Primary	Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)	CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.	Baseline, month 8
Primary	Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)	CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.	Baseline, month 8
Secondary	Change in Insulin Sensitivity	Insulin Sensitivity is a measure of how well the body responds insulin. A higher value indicates a better outcome; a lower value indicates a worse outcome.	Baseline, month 8
Secondary	Change in Renal Vascular Resistance (RVR)	RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.	Baseline, month 8