NCT05819138

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
19mo left

Started Jun 2023

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

April 4, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.3 years

First QC Date

April 4, 2023

Last Update Submit

March 3, 2026

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in Insulin Sensitivity

    Baseline, month 8

  • Change in Renal Vascular Resistance (RVR)

    Baseline, month 8

Study Arms (2)

Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide Pen Injector

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Semaglutide Pen InjectorDRUG

Semaglutide injection

Also known as: Ozempic
Semaglutide
PlaceboDRUG

Semaglutide placebo injection

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-49 years
  • \) 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Washington Medicine Diabetes Institute (UWMDI)

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Petter M Bjornstad, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kristen Nadeau, MD, MS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyla Best

CONTACT

720-777-9500Kyla.Best@cuanschutz.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 19, 2023

Study Start

June 21, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)