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

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

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The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR3824 Placebo

once daily, 12 weeks

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Once daily, 12 weeks

SHR3824 5 mg

once daily, 12 weeks

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

Once daily, 12 weeks

SHR3824 10 mg

once daily, 12 weeks

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

Once daily, 12 weeks

SHR3824 20 mg

once daily, 12 weeks

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

Once daily, 12 weeks

Interventions

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SHR3824

Once daily, 12 weeks

Intervention Type DRUG

Placebo

Once daily, 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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 not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No