Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes

May 17, 2017 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 as Monotherapy in in Chinese Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24 weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

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
      • Beijing, China
        • Chinese PLA General Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have a diagnosis of type 2 diabetes mellitus;
  • Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 8 weeks;
  • FPG<=15mmol/L;
  • Hemoglobin A1c levels >=7.0% and <=10.5%;
  • Body mass index (BMI) 19 to 35 kg/m2;

Exclusion Criteria:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
  • Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
  • Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
  • History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
  • Past or current history of malignant tumor;
  • Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
  • Pregnant women, lactating mothers, or women of childbearing potential;
  • Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR3824 Placebo
once daily, 24 weeks
Drug: Placebo
Once daily, 24 weeks
Experimental: SHR3824 5 mg
once daily, 52 weeks
Drug: SHR3824
Once daily, 52 weeks
Experimental: SHR3824 10 mg
once daily, 52 weeks
Drug: SHR3824
Once daily, 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 24
Baseline to Week 24
The number of volunteers with adverse events as a measure of safety
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

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 (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR3824-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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