Semaglutide Treatment in Type 1 Diabetes

Sponsor
Nordsjaellands Hospital
Study ID
NCT06909006
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Glycemic Control for Diabetes Mellitus
  • Insulin Sensitivity/Resistance
  • Lipidomics
  • Metabolomics
  • Obesity in Diabetes
  • Obesity/Therapy
  • Semaglutide
  • Type 1 Diabetes Mellitus (T1DM)
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 2.4mg — DRUG
    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 — DRUG
    Visually identical and same label as the active comparator intervention

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Mar 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide
    Subcutaneous injection through injector pen with the active comparator Semaglutide once a week in monthly increasing doses as given: 0.25mg - 0.5mg - 1.0mg - 1.7mg - 2.4mg
  • Placebo Comparator: Semaglutide placebo
    Visually identical injector pen without the active comparator.

Primary Outcome Measure

Body weight [ Time Frame: 74 weeks ]

Central Contacts

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