NCT06909006Not yet recruitingPhase 3
Semaglutide Treatment in Type 1 Diabetes
Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- Oct 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Nordsjaellands Hospital
- NCT number
- NCT06909006
- EU CT number
- 2025-522326-13-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 122
- From Oct 2025 to the primary completion date, Jun 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with GLP1-RAs within last 6 months
- Alcohol/drug abuse
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Receipt of an investigational drug within 30 days prior to visit 0 / Simultaneous participation in any other clinical intervention trial
Other illness
- Other forms of diabetes
- History of thyroid adenoma or carcinoma
Lab values
- Liver disease with elevated plasma alanine aminotransferase (ALT) \> five times and plasma aspartate aminotransferase (AST) \> five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
Age
- Cancer, unless in complete remission for \> 5 years or unless basocellular carcinomas
Other
- Known intolerance for semaglutide
- Pregnant or nursing women
- Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
- Acute or chronic pancreatitis
Who the study is looking for
- Type 1 Diabetes for more than 3 years
- BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitet Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Hilleroed | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Koege | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.