Semaglutide Treatment in Type 1 Diabetes

Last updated: August 4, 2025
Sponsor: Nordsjaellands Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 1

Allergy

Obesity

Treatment

Semaglutide 2.4mg

Semaglutide placebo

Clinical Study ID

NCT06909006
U1111-1304-0713
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 orarthrosis

Exclusion

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 andplasma aspartate aminotransferase (AST) > five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, andthe 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'sassessment makes the patient unsuitable for study participation

  • Receipt of an investigational drug within 30 days prior to visit 0 / Simultaneousparticipation in any other clinical intervention trial

Study Design

Total Participants: 122
Treatment Group(s): 2
Primary Treatment: Semaglutide 2.4mg
Phase: 3
Study Start date:
October 01, 2025
Estimated Completion Date:
June 30, 2028

Study 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 all included diabetes care centres will at routine visits be screened for eligibility for the trial and offered participation. If accepted, the patients will be randomised to one of two intervention arms and undergo a series of different examinations prior to start of the intervention.

The two arms consist of treatment with subcutaneous semaglutide injections or subcutaneous injections with semaglutide placebo. The baseline examinations entail documentation of insulin doses, dietary patterns, diabetes distress and treatment satisfaction questionnaires, anthropoimetric data (height, weight and calculation of BMI, waist circumference, waist-hip-ratio), blood work (HbA1c, fasting glucose, fasting c-peptide, lipids, liver and kidney markers incl. Fib-4-scoring, hematology, hsCRP), ECG, capturing of data from continuous/flash glucose monitors.

The first 40 included in the study from the centres of SDCA and NOH will further be examined through hyperinsulinemic euglycemic clamps to determine their insulin sensitivity and asses their transcriptome through muscle and fat cell biopsies in relation to the clamp and also be assessed through DXA scans to look at body composition and bone density.

Patients will then be handed out their trial drug-pens and start the uptitration proces.

The efficacy of semaglutide will be evaluated through the above mentioned array of different investigations by comparing parameters prior to trial drug start, during (throughout the study period), at the end of the drug and at a 6 week post-study followup in an intention-to-treat analysis primarily and secondarily a per-protocol analysis.

The safety will be assessed through evaluation of standardized adverse event reporting (including hypoglycemic events and diabetic ketoacidosis).

Connect with a study center

  • Nordsjaellands Hospital

    Hillerød, 3400
    Denmark

    Site Not Available

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