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Semaglutide Treatment in Type 1 Diabetes

NCT06909006 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-08-08

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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

DRUG

Semaglutide placebo

Visually identical and same label as the active comparator intervention

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Steno Diabetes Center Odense

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital

    collaborator UNKNOWN

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Thomas F Dejgaard, MD, ph.d., endocrinologist · Nordsjaellands Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909006 on ClinicalTrials.gov