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

Phase 1

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

• Registration Number: NCT02366351
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• 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: 2016-01

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 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR3824 Placebo	Placebo	once daily, 12 weeks
SHR3824 5 mg	SHR3824	once daily, 12 weeks
SHR3824 10 mg	SHR3824	once daily, 12 weeks
SHR3824 20 mg	SHR3824	once daily, 12 weeks

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China