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

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: HMS5552

Study type: Interventional

Funder types: Industry

Identifiers

NCT02597400

HMM0104

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

HMS5552 and Metformin

Experimental group

Description:

All subjects will receive the following: * Metformin500 mg BID on Days 1-2, only the morning dose on Day 3. Metformin will be taken 30 minutes prior to meals; * Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals; * HMS5552 50 mg BID on Days 9 -12, only the morning dose on Day 13. HMS5552 will be taken 30 minutes prior to meals.

Treatment:

Drug: Metformin

Drug: HMS5552