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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: SHR3824; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366377

SHR3824-108

Details and patient eligibility

About

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.

Enrollment: 168 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;
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 4 patient groups

SHR3824 Placebo

Experimental group

Description:

SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Treatment:

Drug: Placebo

Drug: Metformin

SHR3824 5 mg

Experimental group

Description:

SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Treatment:

Drug: Metformin

Drug: SHR3824

SHR3824 10 mg

Experimental group

Description:

SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Treatment:

Drug: Metformin

Drug: SHR3824

SHR3824 20 mg

Experimental group

Description:

SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Treatment:

Drug: Metformin

Drug: SHR3824