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โ† Trials
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Glucokinase Activator in Monogenic Diabetes

RecruitingPhase 2Ages 18 Years - 74 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 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
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What it tests

  • Dorzagliatin
  • matched placebo
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Where

1 site
3M, Diabetes and Endocrine Research Center
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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