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

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: SHR3824; Drug: Placebo; Drug: Metformin

• Registration Number: NCT02366377
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-18
• Last Update Submitted: 2015-02-18
• Study First Posted: 2015-02-19
• Last Update Posted: 2015-02-19
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR3824 5 mg	SHR3824	SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 20 mg	SHR3824	SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 Placebo	Placebo	SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 10 mg	SHR3824	SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 20 mg	Metformin	SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 Placebo	Metformin	SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 5 mg	Metformin	SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824 10 mg	Metformin	SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Primary Outcome Measures

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

Secondary Outcome Measures

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