Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
122 participants
INTERVENTIONAL
2025-10-31
2028-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
Semaglutide placebo
Visually identical injector pen without the active comparator.
Semaglutide placebo
Visually identical and same label as the active comparator intervention
Interventions
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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
Semaglutide placebo
Visually identical and same label as the active comparator intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Steno Diabetes Center Odense
OTHER
Zealand University Hospital
OTHER
Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital
UNKNOWN
Nordsjaellands Hospital
OTHER
Responsible Party
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Principal Investigators
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Thomas F Dejgaard, MD, ph.d., endocrinologist
Role: STUDY_CHAIR
Nordsjaellands Hospital
Locations
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Nordsjaellands Hospital
Hillerød, Denmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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U1111-1304-0713
Identifier Type: -
Identifier Source: org_study_id
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