Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

Hua Medicine Limited24 enrolled

Overview

This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

HMS5552DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female,age 18-65 years * Has type 2 diabetes mellitus * BMI 20 to 29kg/m2 * Willingness to adhere to the protocol requirement Exclusion Criteria: * Patients with type1 diabetes mellitus * Received any antidiabetic drug within run-in or during screening * Hepatic diseases * Kidney diseases * Clinical abnormal finding in EVG,labs and physical exams * Women of child-bearing potential

Locations (1)

The 1st Betuhune Hospital of Jilin University

Changchun, China

Outcomes

Primary Outcomes

beta cell function

will be assessed by change of beta cell function index

Time frame: 4 weeks

HbA1

Time frame: 4 weeks

24-hour glucose change

Time frame: 4 weeks

Secondary Outcomes

The study drug concentration in blood samples to be collected after drug administration

Time frame: 4 weeks

Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement

Time frame: 4 weeks

Data from ClinicalTrials.gov

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