Obesity in DiabetesObesity/TherapyType 1 Diabetes Mellitus (T1DM)Insulin Sensitivity/ResistanceSemaglutideLipidomicsMetabolomicsWeight LossGlycemic Control for Diabetes Mellitus
Semaglutide 2.4mg: The active comparator of the intervention is s.c. Semaglutide injection once a week in increasing doses every month from 0.25 mg to 0.5 mg to 1.0 mg to 1.7 mg to 2.4 mg and the placebo comparator is s.c. injection with a visually identical and same label pen as described for the active comparator
Semaglutide placebo: Visually identical and same label as the active comparator intervention
Study 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 hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Body weight — 74 weeks Body weight will be measured both prior to and following treatment for 68 weeks with either semaglutide or placebo. Changes in body weight will be compared for the two intervention arms, before, throughout and at the end of treatment and then at followup 6 weeks later.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.