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Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

Sponsor
Hua Medicine Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02386982
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
2
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. beta cell function [4 weeks]

      will be assessed by change of beta cell function index

    2. HbA1 [4 weeks]

    3. 24-hour glucose change [4 weeks]

    Secondary Outcome Measures

    1. The study drug concentration in blood samples to be collected after drug administration [4 weeks]

    2. Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The 1st Betuhune Hospital of Jilin University Changchun China

    Sponsors and Collaborators

    • Hua Medicine Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hua Medicine Limited
    ClinicalTrials.gov Identifier:
    NCT02386982
    Other Study ID Numbers:
    • HMM0103
    First Posted:
    Mar 12, 2015
    Last Update Posted:
    May 14, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of May 14, 2015