NCT06976658 Glucokinase Activator in Monogenic Diabetes
| NCT ID | NCT06976658 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2025-04-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 and \<75 years 2. body mass index (BMI) \>18 and \<30 kg/m2 3. fasting plasma glucose \>5.6 mmol/L at screening 4. 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 Criteria: 1. Body weight \<45kg at screening 2. Current or planning pregnancy or lactating 3. troke or cardiovascular disease within 6 months of recruitment 4. severe renal dysfunction (estimated glomerular filtration rate \<30mL/min/1.73m2 or renal replacement therapy) 5. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \> 3 times upper limit of normal) 6. history of drug abuse or excessive alcohol intake 7. severe hypoglycemia within 6 months prior to screening 8. anaemia with Hb \<10 g/dL at screening 9. excessive blood loss \>300mL within 1 month of screening 10. use of strong or moderate CYP3A4 inhibitors or inducers 11. 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 12. use of long-term high-dose corticosteroids at randomisation 13. serious concurrent infections at time of screening
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06976658 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06976658 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06976658 currently recruiting?
Yes, NCT06976658 is actively recruiting participants. Contact the research team at e.chow@cuhk.edu.hk for enrollment information.
Where is the NCT06976658 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06976658 clinical trial?
NCT06976658 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 44 participants.
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