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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Dorzagliatin
DrugDorzagliatin 50mg bd
matched placebo
Drugmatched placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fasting plasma glucose
Difference in fasting plasma glucose (FPG) between treatment periods
Time frame
8 weeksSecondary outcomes
1
• HbA1c
Difference between HbA1c at end of treatment periods
Time frame
8 weeks2
CGM metrics time in range
Time in range defined by CGM at end of treatment periods
Time frame
8 weeks3
CGM metric coefficient of variation
Difference in % CV at end of treatment periods
Time frame
8 weeks4
Glucose area under the curve during OGTT
Difference between AUC glucose at end of treament periods
Time frame
8 weeksOther outcomes
1
Treatment-emergent adverse events
Proportion of participants with adverse events in each treatment period
Time frame
8 weeks2
Hypoglycemia
Incidence of hypoglycemic events
Time frame
8 weeks3
Blood pressure
Blood pressure at end of each treatment period
Time frame
8 weeks4
Body weight
Body weight at end of each treatment period
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov