Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus
The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.
This will be a randomized, double-blind and placebo-controlled study with multiple oral doses
of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic
drug for treatment before.
The primary objective is to characterize the safety and tolerability of HMS5552 following
multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8
days.
The secondary objectives include:
1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients
with type 2 diabetes
2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients
with type 2 diabetes
3. To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics
A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose
levels). There will be 8 active and 2 placebo patients in each dose group. The safety,
tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be
reviewed in blinded fashion before escalation to the next dose cohort.
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