To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Tablet, HSK7653 10 mg Q2W, 12 weeks
Tablet, HSK7653 25 mg Q2W, 12 weeks
Tablet, HSK7653 50 mg Q2W, 12 weeks
Peking university people's hospital
Beijing, Beijing Municipality, China
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
Time frame: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Peak plasma concentration (Cmax) of HSK7653
Cmax of HSK7653 after first dose and multi-dose administration
Time frame: Day 1 to Day 43
Area under the plasma concentration versus time curve (AUC) of HSK7653
AUC of HSK7653 after first dose and multi-dose administration
Time frame: Day 1 to Day 43
Half-life (t1/2) of HSK7653
T1/2 of HSK7653 after single-dose and multi-dose administration
Time frame: Day 1 to Day 43
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653
Time frame: Day 1 to Day 84
Change from baseline in GLP-1
Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653
Time frame: Day 1 to Day 84
Change from baseline of fasting plasma glucose
Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653
Time frame: Day 1 to Day 84
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Tablet, 0 mg Q2W, 12 weeks
Change from baseline of HbA1c
Change from baseline in HbA1c after multi-dose administration of HSK7653
Time frame: Day 1 to Day 84