NCT05819138 Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
| NCT ID | NCT05819138 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Colorado, Denver |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-06-21 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2023-06-21 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 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
Contact & Investigator
Petter M Bjornstad, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05819138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05819138 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT05819138 currently recruiting?
Yes, NCT05819138 is actively recruiting participants. Contact the research team at Kyla.Best@cuanschutz.edu for enrollment information.
Where is the NCT05819138 trial being conducted?
This trial is being conducted at Aurora, United States, Seattle, United States.
Who is sponsoring the NCT05819138 clinical trial?
NCT05819138 is sponsored by University of Colorado, Denver. The principal investigator is Petter M Bjornstad, MD at University of Washington. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.