Diabetes Mellitus, Type 1Phase 3T1-DISCONCT05819138
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
A Phase 3 study testing Semaglutide Pen Injector in people with Diabetes Mellitus, Type 1, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2023to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Kyla Best, 720-777-9500, Kyla.Best@cuanschutz.edu
Kristen Nadeau, MD, MS
- Recruiting
University of Washington Medicine Diabetes Institute (UWMDI)
Seattle, Washington, 98109
Amanda Bard, 504-521-7822, abard@uw.edu
Petter Bjornstad, M.D.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Semaglutide Pen Injector, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Ozempic
Semaglutide injection
PlaceboDrug
Semaglutide placebo injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, month 8
Secondary outcomes (2)
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.
Measured: Baseline, month 8
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.
Measured: Baseline, month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start21 Jun 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Petter M Bjornstad, MD, Principal investigator, University of WashingtonKristen Nadeau, MD, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819138
- Sponsor's protocol ID
- 22-0794
- Other IDs
- R01HL165433
- Acronym
- T1-DISCO
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT05819138
- Acronym / sponsor ID
- T1-DISCO / 22-0794
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide Pen InjectorParticipants 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 comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen InjectorAlso: OzempicSemaglutide injection | Drug | Semaglutide |
| PlaceboSemaglutide placebo injection | Drug | Placebo |
Primary outcome
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, month 8
CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
2 secondary outcomes
Change in Insulin Sensitivity
Time frame: Baseline, month 8
Change in Renal Vascular Resistance (RVR)
Time frame: Baseline, month 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petter M Bjornstad, MD principal investigator
University of Washington
Kristen Nadeau, MD, MS principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide Pen Injector in people with Diabetes Mellitus, Type 1, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyla Best (720-777-9500, Kyla.Best@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ascending Aortic Pulse Wave Velocity (AA PWV) (time frame: Baseline, month 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.