Clinical trial NCT02597400: Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: The primary pharmacokinetics parameters of Cmax To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
timeFrame: 13 days
Secondary outcomes:
measure: The pharmacokinetics parameters of Tmax To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
timeFrame: 13 days
measure: The pharmacokinetics parameters of AUC0-24hr To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
timeFrame: 13 days
measure: Safety assessments includes monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, resting 12-lead electrocardiograms (ECGs), and physical examination findings.
timeFrame: 13 days
measure: Pharmacodynamic responses (serum levels) of glucose, insulin and C-peptide will be evaluated.
timeFrame: 13 days
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Frontage Clinical Services Inc.
state: New Jersey
Study officials:
affiliation: Frontage Clinical Services, Inc.
name: Gregory J Tracey, MD
role: PRINCIPAL_INVESTIGATOR
References: