Up-titration of sulfonylurea (SU) in individuals with HNF1A- and HNF4A-MODY – A Steno MODERN-MODY project (MM-SUUP)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

14 Apr 2026 → ongoing

Decision date (initial)

2026-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

DexCom, Inc. · Novo Nordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

We aim to systematically assess the effects of up-titration of glimepiride on continuous glucose monitoring (CGM) metrics in individuals diagnosed with HNF1A- or HNF4A-MODY including those who have previously been treated as individuals with T1D or T2D.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. HbA1c ≥48 mmol/mol and/or current insulin treatment
2. Age ≥18 years
3. Diabetes caused by a heterozygous mutation (pathogenic or likely pathogenic according to ACMG criteria) in the HNF1A-gene or HNF4A-gene
4. Informed consent

Exclusion criteria 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 21

1. Mean difference in CGM-metric, mean glucose, measured at baseline and in the last two weeks of the intervention
2. Mean difference in CGM-metric, coefficient of variation (CV%), measured at baseline and in the last two weeks of the intervention
3. Mean difference in CGM-metric, standard deviation (SD), measured at baseline and in the last two weeks of the intervention
4. 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
5. 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
6. Mean difference in haemoglobin A1c (HbA1c)
7. Mean difference in total plasma glucose AUC obtained from the OGTT
8. Mean difference in total plasma C-peptide AUC obtained from the OGTT
9. Mean time to ceased SU titration
10. Mean tolerable dose of SU
11. Difference in proportion of individuals on any insulin treatment and stratified by insulin type (prandial/basal)
12. Mean difference in daily dose of insulin (only for insulin-treated individuals at baseline)
13. Mean difference in BMI
14. Mean difference in waist-to-height ratio
15. Mean difference in body fat mass
16. Rate ratio of hypoglycaemic events measured by CGM stratified by severity and study phase (up-titration and maintenance)
17. Difference in proportion of participants with hypoglycaemic events measured by CGM stratified by severity (maintenance phase only)
18. Mean difference in percentage of time <3.9 mmol/l
19. Mean difference in percentage of time <3.0 mmol/l
20. Rate ratio of participant-reported hypoglycaemic events stratified by severity and study phase
21. Difference in proportion of participants with participant-reported hypoglycaemic events stratified by severity (maintenance phase only)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Henrik Vestergaard

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Johanne Skov Jensen

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications