Status:
NOT_YET_RECRUITING
Semaglutide Treatment in Type 1 Diabetes
Lead Sponsor:
Nordsjaellands Hospital
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Steno Diabetes Center Odense
Conditions:
Obesity in Diabetes
Obesity/Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 hyp...
Detailed Description
This is a multicentre, randomised, double-blinded, placebo-controlled and investigator-initiated trial aimed to investigate the efficacy of semaglutide in patients with Type 1 Diabetes. Patients from...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Treated with GLP1-RAs within last 6 months
- Known intolerance for semaglutide
- Other forms of diabetes
- Pregnant or nursing women
- Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
- 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)
- Acute or chronic pancreatitis
- Cancer, unless in complete remission for \> 5 years or unless basocellular carcinomas
- History of thyroid adenoma or carcinoma
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06909006
Start Date
October 1 2025
End Date
June 1 2028
Last Update
August 8 2025
Active Locations (1)
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1
Nordsjaellands Hospital
Hillerød, Denmark, Denmark, 3400