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

A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Glucokinase (GK) Activator HMS5552 and Metformin in Patients With Type 2 Diabetes Mellitus (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).

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;