Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM

This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK
activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM). The study
is to assess the potential pharmacokinetic interaction between HMS5552 and metformin in
subjects with T2DM. The study is also to evaluate the safety and tolerability of HMS5552
with simultaneous administration of metformin in subjects with T2DM.

Inclusion Criteria:

- Male and/or female subjects between the ages of 18 and 70 years

- Body Mass Index (BMI) of approximately 22 to 38kg/m2

- HbA1c ≥7% and ≤12%

- Are capable of giving informed consent and complying with study procedures

Exclusion Criteria:

- fasting blood glucose ≤110 or ≥270mg/dL

- Type 1 diabetes mellitus, or latent autoimmune diabetes in adults

- History or symptoms of clinically significant cardiovascular disease, particularly
coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease
within one year of screening

- History of liver disease and clinically significant renal disease

- Known hypersensitivity to metformin hydrochloride;

- Positive pregnancy test result;