Status:
NOT_YET_RECRUITING
Glucokinase Activator in Monogenic Diabetes
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetes Mellitus
Monogenic Diabetes
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Detailed Description
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Eligibility Criteria
Inclusion
- 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
- 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
- excessive blood loss \>300mL within 1 month of screening
- use of strong or moderate CYP3A4 inhibitors or inducers
- use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation
- use of long-term high-dose corticosteroids at randomisation
- serious concurrent infections at time of screening
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06976658
Start Date
May 28 2025
End Date
December 31 2026
Last Update
May 16 2025
Active Locations (1)
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1
3M, Diabetes and Endocrine Research Center
Hong Kong, Hong Kong