Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Phase 3

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Semaglutide Pen Injector; Drug: Placebo

• Registration Number: NCT05819138
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-19
• Study Start: 2023-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18-49 years
• 1. T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide	Semaglutide Pen Injector	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)	Baseline, month 8	AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.
Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)	Baseline, month 8	CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)	Baseline, month 8	CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Renal Vascular Resistance (RVR)	Baseline, month 8	RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.
Change in Insulin Sensitivity	Baseline, month 8	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.

Trial Locations

Locations (2)

University of Washington Medicine Diabetes Institute (UWMDI); 🇺🇸 Seattle, Washington, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States