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Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes (T1-DISCO)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Semaglutide Pen Injector
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18-40 years Antibody + Type 1 Diabetes (T1D) <30 years, ≥ 10 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 20-35 kg/m2 Adequate contraceptive method for females Exclusion Criteria: HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization Congenital heart disease, anemia, diabetic 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 Significant systemic illness such as cancer MRI or p-aminohippuric acid (PAH) contraindications, Iodine or glucagon-like peptide-1 receptor agonist (GLP-1RA) allergy

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 4, 2023
Last Updated
April 20, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05819138
Brief Title
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Acronym
T1-DISCO
Official Title
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide Pen Injector
Other Intervention Name(s)
Ozempic
Intervention Description
Semaglutide injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Semaglutide placebo injection
Primary Outcome Measure Information:
Title
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
Description
AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.
Time Frame
Baseline, month 8
Title
Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)
Description
CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
Time Frame
Baseline, month 8
Title
Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)
Description
CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
Time Frame
Baseline, month 8
Secondary Outcome Measure Information:
Title
Change in Insulin Sensitivity
Description
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.
Time Frame
Baseline, month 8
Title
Change in Renal Vascular Resistance (RVR)
Description
RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.
Time Frame
Baseline, month 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-40 years Antibody + Type 1 Diabetes (T1D) <30 years, ≥ 10 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 20-35 kg/m2 Adequate contraceptive method for females Exclusion Criteria: HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization Congenital heart disease, anemia, diabetic 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 Significant systemic illness such as cancer MRI or p-aminohippuric acid (PAH) contraindications, Iodine or glucagon-like peptide-1 receptor agonist (GLP-1RA) allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Baumgartner, MSEd
Phone
720-777-5774
Email
amy.baumgartner@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter M Bjornstad, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristen Nadeau, MD, MS
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Baumgartner, MS
Phone
720-777-5774
Email
amy.baumgartner@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Petter Bjornstad, MD
First Name & Middle Initial & Last Name & Degree
Kristen Nadeau, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

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