2025-523414-89-00RecruitingPhase 2
Effects of semaglutide as add-on therapy to sulfonylurea on plasma glucose in individuals with HNF1A- and HNF4A-MODY – A Steno MODERN-MODY project (MM-SEMA)
Steno Diabetes Center Copenhagen3 sites in 1 country54 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 54
- Locations
- 3
- Primary Endpoint
- Mean difference in mean sensor glucose measured by CGM during the last two weeks of each treatment period
Study Overview
Brief Summary
To investigate the glucose-lowering effect of once-weekly administered semaglutide (0.25-0.5 mg) in individuals with HNF1A- and HNF4A-MODY.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to provide informed consent before any trial-related activities
- •Diabetes caused by a heterozygous pathogenic or likely pathogenic variant in HNF1A or HNF4A (according to ACMG criteria)
- •Age ≥18 years
- •HbA1c ≥48 mmol/mol OR treatment with insulin in the preceding 90 days
- •Treatment with sulfonylurea in the preceding 90 days
Exclusion Criteria
- •Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures
- •Previous randomisation in this trial
- •History of acute and/or chronic pancreatitis
- •End-stage liver disease
- •eGFR <15 ml/min/1.73m2
- •Treatment for proliferative retinopathy within 90 days prior to screening
- •Known or suspected allergy to trial medication(s), excipients, or related products
- •Treatment with GLP-1RA within 60 days prior to screening
- •Treatment with DPP-4 inhibitor or SGLT2 inhibitor within 30 days prior to screening
- •Inability (judged by investigator) or unwillingness (of the potential participant) to abstain from a variable dosing regimen of glucose-lowering drugs (i.e., SU, repaglinide or insulin (prandial insulin) in a self-titrated regimen) during the study
Outcomes
Primary Outcomes
Mean difference in mean sensor glucose measured by CGM during the last two weeks of each treatment period
Mean difference in mean sensor glucose measured by CGM during the last two weeks of each treatment period
Secondary Outcomes
- Mean difference in CGM-metric, coefficient of variation (CV%), during the last two weeks of each treatment period
- Mean difference in CGM-metric, standard deviation (SD), during the last two weeks of each treatment period
- Mean difference in CGM-metric, time in range (3.9–10 mmol/l), during the last two weeks of each treatment period
- Mean difference in CGM-metric, time above range (>10 mmol/l), during the last two weeks of each treatment period
- Mean difference in glycated haemoglobin A1c (HbA1c) measured at the last visit of each intervention period
- Mean difference in fasting plasma C-peptide (relative difference, %) measured at the last visit of each intervention period
- Mean difference in fasting plasma glucose measured at the last visit of each intervention period
- Mean difference in body mass index measured at the last visit of each intervention period
- Mean difference in waist-to-height ratio measured at the last visit of each intervention period
- Mean difference in body fat (kg) measured at the last visit of each intervention period
- Rate ratio of hypoglycaemic events measured by CGM during the last two weeks of each intervention stratified by severity (level 1, 2, and 3)
- Difference in proportion of participants with hypoglycaemic events measured by CGM stratified by severity in the last two weeks of each intervention
- Mean difference in percentage of time <3.9 mmol/l between the last two weeks of each intervention period
- Mean difference in percentage of time <3.0 mmol/l between the last two weeks of each intervention period
- Rate ratio of participant-reported hypoglycaemic events stratified by severity during the maintenance phase (last 6 weeks of each intervention period)
- Difference in proportion of participants with participant-reported hypoglycaemic events stratified by severity during the maintenance phase (last 6 weeks of each intervention period)
- Rate ratio of participant-reported hypoglycaemic events stratified by severity during the uptitrationphase (first 10 weeks of each intervention period)
- Difference in proportion of participants with participant-reported hypoglycaemic events stratified by severity during the uptitration phase (first 10 weeks of each intervention period)
Investigators
Henrik Vestergaard
Scientific
Steno Diabetes Center Copenhagen
Study Sites (3)
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