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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hua Medicine Limited
• Treatments: Metformin

Criteria

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;