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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)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523414-89-00
Enrollment
54
Registered
2026-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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)

Interventions

DRUGSEMAGLUTIDE
DRUGPlacebo for semaglutide (injectable)

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 (k

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 9, 2026