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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: SHR3824; Drug: metformin

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Third Affiliated Hospital of Sun Yat - sen University
      • Contact: Weng Jianping, professor; Phone Number: 86-(20)85253239; Email: wjianp@mail.sysu.edu.cn
      • Contact: Chen Jianwen; Phone Number: 18036611985; Email: chenjianwen@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR3824+Metformin, Placebo+Metformin; once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks	Drug: Placebo; Once daily, 24 weeks
Experimental: SHR3824 5 mg+Metformin; once daily for SHR3824, three times daily for metformin, 52 weeks	Drug: SHR3824; Once daily, 52 weeks; Drug: metformin; Three times daily, 52 weeks
Experimental: SHR3824 10 mg+Metformin; once daily for SHR3824, three times daily for metformin, 52 weeks	Drug: SHR3824; Once daily, 52 weeks; Drug: metformin; Three times daily, 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: SHR3824-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No