GLIMEPIRIDE for HNF1A-MODY | HNF4A-MODY

Inclusion criteria

• {"criterion_text":"- HbA1c ≥48 mmol/mol and/or current insulin treatment\n- Age ≥18 years\n- Diabetes caused by a heterozygous mutation (pathogenic or likely pathogenic according to ACMG criteria) in the HNF1A-gene or HNF4A-gene\n- Informed consent"}

Exclusion criteria

• {"criterion_text":"- Breastfeeding, pregnancy or inadequate contraceptive methods in women with childbearing potential\n- Nephropathy (eGFR <30 ml/min/1.73 m2 and/or persistent severely increased albuminuria (urine-albumin-creatinine ratio >300 mg/g))\n- End-stage liver disease\n- Contraindications for use of specific CGM device (e.g. non-manageable skin reactions, use of substances interfering with measurements etc.)\n- Known allergic reaction to study drug (glimepiride or other sulphonamides)\n- Treatment with SU or glinides within the last 30 days"}

Primary endpoints

• {"endpoint_text":"- Mean difference in time in tight range (3.9 – 7.8 mmol/l) measured by CGM in a two week-period at baseline and in the last two weeks of the intervention period","definition_or_measurement_approach":"Measured by continuous glucose monitoring (CGM); comparison of two-week period at baseline versus last two weeks of the intervention period."}

Secondary endpoints

• {"endpoint_text":"- Mean difference in CGM-metric, mean glucose, measured at baseline and in the last two weeks of the intervention\n- Mean difference in CGM-metric, coefficient of variation (CV%), measured at baseline and in the last two weeks of the intervention\n- Mean difference in CGM-metric, standard deviation (SD), measured at baseline and in the last two weeks of the intervention\n- Mean difference in CGM-metric, percentage of time in range (3.9–10 mmol/l), measured at baseline and in the last two weeks of the intervention\n- Mean difference in CGM-metric, percentage of time above range (>10 mmol/l), measured at baseline and in the last two weeks of the intervention\n- Mean difference in haemoglobin A1c (HbA1c)\n- Mean difference in total plasma glucose AUC obtained from the OGTT\n- Mean difference in total plasma C-peptide AUC obtained from the OGTT\n- Mean time to ceased SU titration\n- Mean tolerable dose of SU\n- Difference in proportion of individuals on any insulin treatment and stratified by insulin type (prandial/basal)\n- Mean difference in daily dose of insulin (only for insulin-treated individuals at baseline)\n- Mean difference in BMI\n- Mean difference in waist-to-height ratio\n- Mean difference in body fat mass\n- Rate ratio of hypoglycaemic events measured by CGM stratified by severity and study phase (up-titration and maintenance)\n- Difference in proportion of participants with hypoglycaemic events measured by CGM stratified by severity (maintenance phase only)\n- Mean difference in percentage of time <3.9 mmol/l\n- Mean difference in percentage of time <3.0 mmol/l\n- Rate ratio of participant-reported hypoglycaemic events stratified by severity and study phase\n- Difference in proportion of participants with participant-reported hypoglycaemic events stratified by severity (maintenance phase only)","definition_or_measurement_approach":"Most secondary endpoints are measured by CGM comparing baseline and last two weeks of intervention; others include laboratory-derived AUCs from OGTT, HbA1c measurement, participant-reported hypoglycaemic events, and insulin dose comparisons as specified."}

Denmark

Earliest CTIS Part Ii Submission Date

23-02-2026

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

9

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Steno Diabetes Center Copenhagen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"DexCom, Inc.","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Novo Nordisk Foundation","duties_or_roles":"Monetary support","organisation_type":""}