The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

February 18, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 1

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;
  • Hemoglobin A1c levels >=7.5% and <=10.5%;
  • Body mass index (BMI) 25 to 45 kg/m2;
  • Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

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
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Experimental: SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Experimental: SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Experimental: SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 12
Baseline to Week 12
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame: Baseline to Week 12
Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

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

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

February 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

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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