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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SHR3824; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03159052

SHR3824-301

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups

SHR3824 Placebo

Experimental group

Description:

once daily, 24 weeks

Treatment:

Drug: Placebo

SHR3824 5 mg

Experimental group

Description:

once daily, 52 weeks

Treatment:

Drug: SHR3824

SHR3824 10 mg

Experimental group

Description:

once daily, 52 weeks

Treatment:

Drug: SHR3824