Semaglutide Treatment in Type 1 Diabetes (OBES1TY)

Nordsjaellands Hospital

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Drug: Semaglutide 2.4mg; Drug: Semaglutide placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06909006

U1111-1304-0713

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 or arthrosis

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

Semaglutide

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide 2.4mg

Semaglutide placebo

Placebo Comparator group

Description:

Visually identical injector pen without the active comparator.

Treatment:

Drug: Semaglutide placebo