Actively Recruiting
Glucokinase Activator in Monogenic Diabetes
Led by Chinese University of Hong Kong · Updated on 2026-04-30
44
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
CONDITIONS
Official Title
Glucokinase Activator in Monogenic Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 75 years
- Body mass index (BMI) greater than 18 and less than 30 kg/m2
- Fasting plasma glucose greater than 5.6 mmol/L at screening
- Confirmed heterozygous carrier of a pathogenic or likely pathogenic glucokinase (GCK) mutation based on established genetic guidelines
You will not qualify if you...
- Body weight less than 45 kg at screening
- Current or planning pregnancy or lactating
- Stroke or cardiovascular disease within 6 months before recruitment
- Severe kidney dysfunction (estimated glomerular filtration rate less than 30 mL/min/1.73 m2 or on renal replacement therapy)
- Severe liver dysfunction (liver enzymes more than 3 times the upper limit of normal)
- History of drug abuse or excessive alcohol use
- Severe low blood sugar episodes within 6 months before screening
- Anemia with hemoglobin less than 10 g/dL at screening
- Excessive blood loss over 300 mL within 1 month before screening
- Use of strong or moderate CYP3A4 inhibitors or inducers
- Use of certain diabetes medications (sulfonylureas, DPP-4 inhibitors, GLP-1 agonists, SGLT2 inhibitors, insulin, thiazolidinediones, acarbose) within 6 weeks before randomization
- Use of long-term high-dose corticosteroids at randomization
- Serious infections at the time of screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
3M, Diabetes and Endocrine Research Center
Hong Kong, Hong Kong
Actively Recruiting
Research Team
E
Elaine Chow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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