Glucokinase Activator in Monogenic Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorChinese University of Hong Kong
About this trial
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Eligibility criteria
Qualifiers
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) .
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Dorzagliatin
- matched placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov