Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients

NCT ID: NCT02386982

Last Updated: 2015-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HMS5552 dose 1

HMS5552 75mg.Oral administration,twice per day.

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

HMS5552 dose 2

HMS5552 75mg.Oral administration,once per day.

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

Interventions

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HMS5552

Intervention Type DRUG

Other Intervention Names

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Sinogliatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hua Medicine Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The 1st Betuhune Hospital of Jilin University

Changchun, , China

Site Status

Countries

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China

Other Identifiers

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HMM0103

Identifier Type: -

Identifier Source: org_study_id

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