Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

May 13, 2015 updated by: Hua Medicine Limited

A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changchun, China
        • The 1st Betuhune Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMS5552 dose 1
HMS5552 75mg.Oral administration,twice per day.
Drug: HMS5552
Other Names:
  • Sinogliatin
Experimental: HMS5552 dose 2
HMS5552 75mg.Oral administration,once per day.
Drug: HMS5552
Other Names:
  • Sinogliatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
beta cell function
Time Frame: 4 weeks
will be assessed by change of beta cell function index
4 weeks
HbA1
Time Frame: 4 weeks
4 weeks
24-hour glucose change
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The study drug concentration in blood samples to be collected after drug administration
Time Frame: 4 weeks
4 weeks
Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Medicine Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMM0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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