Glucokinase Activator in Monogenic Diabetes
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Monogenic Diabetes
In brief
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Key facts
- Study ID
- NCT06976658
- Run by
- Chinese University of Hong Kong
- People needed
- 44
- Starts
- 2025-04-30
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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) .
You may not qualify if…
- 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
Where it is running
- 3M, Diabetes and Endocrine Research Center — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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