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

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT02597400

Run by

Hua Medicine Limited

People needed

12

Starts

2015-10-01

Expected to finish

2015-10-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Frontage Clinical Services Inc. — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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