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.
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
Treated with GLP1-RAs within last 6 months
Known intolerance for semaglutide
Other forms of diabetes
Pregnant or nursing women
Parallel
Semaglutide 2.4mg
DrugThe 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
DrugVisually identical and same label as the active comparator intervention
Body weight
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.
Systolic blood pressure
Systolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Diastolic blood pressure
Diastolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Resting heart rate
Systolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Waist circumference
Waist circumference will be assessed and evaluated for changes during and after treatment for 68 weeks with semaglutide compared to before treatment.
Patient reported outcome measures - Dietary patterns
Questionnaires (DNBCs FFQ) will be analyzed to evaluate changes in dietary patterns before treatment, throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Patient reported outcome measures - Diabetes treatment satisfaction
Questionnaires (DTSQ-s and DTSQ-c) will be analyzed to evaluate changes in diabetes treatment satisfaction before treatment, throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Patient reported outcome measures - Diabetes distress
Questionnaires (PAID) will be analyzed to evaluate changes in diabetes treatment satisfaction before treatment, throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Adverse events
Tolerability will be assessed through standardized adverse event reporting (including episodes of hypoglycemia) throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
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Nordsjaellands Hospital
Lead sponsor
Steno Diabetes Center Copenhagen
Collaborator
Steno Diabetes Center Odense
Collaborator
Zealand University Hospital
Collaborator
Aarhus University Hospital
Collaborator
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