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)

Condition studied

Maturity-onset diabetes of the young type 3 (HNF1A-MODY), Maturity-onset diabetes of the young type 1 (HNF4A-MODY)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Mean difference in mean sensor glucose measured by CGM during the last two weeks of each treatment period

Endpoint detail

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)