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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 as Monotherapy in in Chinese Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03159052
• Other study ID #: SHR3824-301
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 17, 2017
• Last updated: May 17, 2017
• Start date: June 2017
• Est. completion date: June 2019

Study information

• Verified date: May 2017
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 2019
• Est. primary completion date: October 2018
• 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;

• 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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SHR3824
Once daily, 52 weeks
• Placebo
Once daily, 24 weeks

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

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		Baseline to Week 24
Primary	The number of volunteers with adverse events as a measure of safety		Baseline to Week 52
Secondary	Adjusted Mean Change in Fasting Plasma Glucose		Baseline to Week 24