NCT02386982

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

March 5, 2015

Last Update Submit

May 13, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • beta cell function

    will be assessed by change of beta cell function index

    4 weeks

  • HbA1

    4 weeks

  • 24-hour glucose change

    4 weeks

Secondary Outcomes (2)

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

    4 weeks

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

    4 weeks

Study Arms (2)

HMS5552 dose 1

EXPERIMENTAL

HMS5552 75mg.Oral administration,twice per day.

Drug: HMS5552

HMS5552 dose 2

EXPERIMENTAL

HMS5552 75mg.Oral administration,once per day.

Drug: HMS5552

Interventions

HMS5552DRUG
Also known as: Sinogliatin
HMS5552 dose 1HMS5552 dose 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female,age 18-65 years
  • Has type 2 diabetes mellitus
  • BMI 20 to 29kg/m2
  • Willingness to adhere to the protocol requirement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Betuhune Hospital of Jilin University

Changchun, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 12, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

CN(1)