Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
NCT ID: NCT05819138
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2023-06-21
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Semaglutide
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.
Semaglutide Pen Injector
Semaglutide injection
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.
Placebo
Semaglutide placebo injection
Interventions
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Semaglutide Pen Injector
Semaglutide injection
Placebo
Semaglutide placebo injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
49 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Petter M Bjornstad, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Kristen Nadeau, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Washington Medicine Diabetes Institute (UWMDI)
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-0794
Identifier Type: -
Identifier Source: org_study_id
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