A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
chronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)
Phase 1 Clinical Trial Centre
Hong Kong, Hong Kong
Acute Insulin secretion
Acute (first phase) insulin response (AIRg) to glucose will be calculated as the mean incremental responses above baseline (average of -20 and -10 and 0 minutes) to the samples drawn at 2, 4, 6, 8 and 10 minutes of the hyperglycemic clamp.
Time frame: At baseline and after 4 weeks of study drug treatment
Second phase insulin secretion
The mean incremental insulin levels between 60 to 90 minutes of hyperglycemic clamp
Time frame: At baseline and after 4 weeks of study drug treatment
Beta cell glucose sensitivity
Beta cell glucose sensitivity will be calculated as increment of insulin secretion in 60-90 minutes of the clamp minus basal insulin divided by glucose change in the same period
Time frame: At baseline and after 4 weeks of study drug treatment
Glucagon-like peptide -1 (GLP-1)
GLP-1 secretion Area under the curve (0-270 minute during hyperglyemic- OGTT clamp study)
Time frame: At baseline and after 4 weeks of study drug treatment
Glucagon
Glucagon area under the curve (0-270 minute) during hyperglyemic- OGTT clamp
Time frame: At baseline and after 4 weeks of study drug treatment
Incretin effect
Difference between the post prandial (100-270min) and preprandial (60-90min) C peptide response
Time frame: At baseline and after 4 weeks of study drug treatment
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