Glucokinase Activator in Monogenic Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dorzagliatin, matched placebo.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Monogenic Diabetes. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial
Overview
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
Interventions
- Drug Dorzagliatin
Dorzagliatin 50mg bd - Drug matched placebo
matched placebo
Primary outcome measures
- Fasting plasma glucose [Time frame: 8 weeks]
Secondary outcome measures (6)
- • HbA1c [Time frame: 8 weeks]
- CGM metrics time in range [Time frame: 8 weeks]
- CGM metric coefficient of variation [Time frame: 8 weeks]
- Glucose area under the curve during OGTT [Time frame: 8 weeks]
- Insulin area under the curve during OGTT [Time frame: 8 weeks]
- GLP1 area under the curve during OGTT [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- 3M, Diabetes and Endocrine Research Center — Hong Kong
Identifiers
NCT: NCT06976658 · RESENSE