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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390295
• Other study ID #: SHR3824-302
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2, 2017
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: WENG Jianping, professor
• Phone: 86-020-85250217
• Email: wjianp[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Placebo
Once daily, 24 weeks
• SHR3824
Once daily, 52 weeks
• metformin
Three times daily, 52 weeks

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat - sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c Levels	Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group	Baseline to Week 24
Secondary	Adjusted Mean Change in Fasting Plasma Glucose	Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group	Baseline to Week 24
Secondary	The number of volunteers with adverse events as a measurement of safety	Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group	Baseline to Week 52