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

NCT ID: NCT02597400

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-10-31

Brief 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).

Detailed 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HMS5552 and Metformin

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

• 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

Intervention Type: DRUG

• 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.

Interventions

Metformin

• 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

Intervention Type: DRUG

HMS5552

• 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.

Intervention Type: DRUG

Other Intervention Names

Glucophage®; GKA

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hua Medicine Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory J Tracey, MD

Role: PRINCIPAL_INVESTIGATOR

Frontage Clinical Services, Inc.

Locations

Frontage Clinical Services Inc.

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

HMM0104

Identifier Type: -

Identifier Source: org_study_id