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)
Key facts
- Where
- Aarhus, Herlev és Odense, DániaSee the 3 sites
- Phase
- 2. fázis
Where in Dánia
- Aarhus University HospitalAarhus, DániaToborzás még nem indult
- Steno Diabetes Center CopenhagenHerlev, DániaToborzás még nem indult
- Odense University HospitalOdense, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- EU 2025-523414-89-00
- Record updated
- 2026. szeptember 8.
- Original description
To investigate the glucose-lowering effect of once-weekly administered semaglutide (0.25-0.5 mg) in individuals with HNF1A- and HNF4A-MODY.Read full original descriptionShow less
To investigate the glucose-lowering effect of once-weekly administered semaglutide (0.25-0.5 mg) in individuals with HNF1A- and HNF4A-MODY.
Inclusion: 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: Previous randomisation in this trial; Treatment for proliferative retinopathy within 90 days prior to screening; Treatment with GLP-1RA within 60 days prior to screening; Treatment with DPP-4 inhibitor or SGLT2 inhibitor within 30 days prior to screening; History of acute and/or chronic pancreatitis; End-stage liver disease; Known or suspected allergy to trial medication(s), excipients, or related products; eGFR <15 ml/min/1.73m2; 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; Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures.