Clinical trial

Semaglutide Treatment in Type 1 Diabetes

Opening soon · Phase 3 · 1 countries · Registry ID NCT06909006

Opening soonPhase 3Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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

Treatments and study arms

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

Semaglutide placebo

Drug

Visually identical and same label as the active comparator intervention

Primary outcomes

Body weight74 weeks

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nordsjaellands Hospital🇩🇰 Hillerød, Denmark, Denmark

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

Email · Call 0045 26 79 61 03

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

Email · Call 0045 42 37 58 40

Thomas F Dejgaard, MD, ph.d., endocrinologistPrincipal Investigator