Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: metformin; Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390295

SHR3824-302

Details and patient eligibility

About

The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.

Full description

A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.

Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group

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;
• Patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day;
• 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+Metformin, Placebo+Metformin

Experimental group

Description:

once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks

Treatment:

Drug: Placebo

SHR3824 5 mg+Metformin

Experimental group

Description:

once daily for SHR3824, three times daily for metformin, 52 weeks

Treatment:

Drug: metformin

Drug: SHR3824

SHR3824 10 mg+Metformin

Experimental group

Description:

once daily for SHR3824, three times daily for metformin, 52 weeks

Treatment:

Drug: metformin

Drug: SHR3824