RecruitingPhase 2

Glucokinase Activator in Monogenic Diabetes

Hong Kong44 participantsStarted 2025-04-30

Plain-language summary

Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. Age ≥18 and \<75 years
✓. body mass index (BMI) \>18 and \<30 kg/m2
✓. fasting plasma glucose \>5.6 mmol/L at screening
✓. Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) .

Exclusion criteria

✕. Body weight \<45kg at screening
✕. Current or planning pregnancy or lactating
✕. troke or cardiovascular disease within 6 months of recruitment
✕. severe renal dysfunction (estimated glomerular filtration rate \<30mL/min/1.73m2 or renal replacement therapy)
✕. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \> 3 times upper limit of normal)
✕. history of drug abuse or excessive alcohol intake
✕. severe hypoglycemia within 6 months prior to screening
✕. anaemia with Hb \<10 g/dL at screening

What they're measuring

Fasting plasma glucose

Timeframe: 8 weeks

Trial details

NCT IDNCT06976658

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Elaine Chow, MD

+852 35051641 e.chow@cuhk.edu.hk

View on ClinicalTrials.gov More Diabetes Mellitus trials