Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Dorzagliatin 50mg bd
matched placebo
3M, Diabetes and Endocrine Research Center
Hong Kong, Hong Kong
Fasting plasma glucose
Difference in fasting plasma glucose (FPG) between treatment periods
Time frame: 8 weeks
• HbA1c
Difference between HbA1c at end of treatment periods
Time frame: 8 weeks
CGM metrics time in range
Time in range defined by CGM at end of treatment periods
Time frame: 8 weeks
CGM metric coefficient of variation
Difference in % CV at end of treatment periods
Time frame: 8 weeks
Glucose area under the curve during OGTT
Difference between AUC glucose at end of treament periods
Time frame: 8 weeks
Insulin area under the curve during OGTT
Difference between AUC insulin at end of treament periods
Time frame: 8 weeks
GLP1 area under the curve during OGTT
Difference between AUC GLP-1 at end of treament periods
Time frame: 8 weeks
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