Semaglutide Treatment in Type 1 Diabetes

NCT06909006 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: U1111-1304-0713
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Semaglutide; Obesity; Type 1 Diabetes; Obese Type 1 Diabetics; Insulin sensitivity; Insulin resistance; Weight loss; GLP1-RA; GLP1; Wegovy

Outcome Measures

Primary Outcomes (1)

• 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.

  74 weeks

Secondary Outcomes (42)

• Systolic blood pressure

  74 weeks

• Diastolic blood pressure

  74 weeks

• Resting heart rate

  74 weeks

• Waist circumference

  74 weeks

• Hip-waist-ratio

  74 weeks

Other Outcomes (4)

• Patient reported outcome measures - Dietary patterns

  74 weeks

• Patient reported outcome measures - Diabetes treatment satisfaction

  74 weeks

• Patient reported outcome measures - Diabetes distress

  74 weeks

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide 2.4mg

Semaglutide placebo

PLACEBO COMPARATOR

Visually identical injector pen without the active comparator.

Drug: Semaglutide placebo

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

Also known as: Active semaglutide

Semaglutide

Semaglutide placebo DRUG

Visually identical and same label as the active comparator intervention

Also known as: Placebo semaglutide

Semaglutide placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Steno Diabetes Center Copenhagen: collaborator
• Steno Diabetes Center Odense: collaborator
• Zealand University Hospital: collaborator
• Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital: collaborator

Study Sites (1)

Nordsjaellands Hospital

Hillerød, Denmark, 3400, Denmark

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 1; Insulin Resistance; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Body Weight Changes

Study Officials

• Thomas F Dejgaard, MD, ph.d., endocrinologist

  Nordsjaellands Hospital

  STUDY CHAIR

Central Study Contacts

Thomas F Dejgaard, MD, ph.d., endocrinologist

CONTACT

0045 26 79 61 03; Thomas.fremming.dejgaard@regionh.dk

Hasan I Mirza, MD, ph.d.-student

CONTACT

0045 42 37 58 40; hasan.imran.mirza@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blinded, placebo-controlled.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

DK (1)