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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390295
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo Drug: SHR3824 Drug: metformin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]
    Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group


Secondary Outcome Measures :
  1. Adjusted Mean Change in Fasting Plasma Glucose [ Time Frame: Baseline to Week 24 ]
    Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group

  2. The number of volunteers with adverse events as a measurement of safety [ Time Frame: Baseline to Week 52 ]
    Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390295


Contacts
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Contact: WENG Jianping, professor 86-020-85250217 wjianp@mail.sysu.edu.cn
Contact: CHEN Jianwen, professor 18036611985 chenjianwen@hrglobe.cn

Locations
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China, Guangdong
Third Affiliated Hospital of Sun Yat - sen University Recruiting
Guangzhou, Guangdong, China
Contact: Weng Jianping, professor    86-(20)85253239    wjianp@mail.sysu.edu.cn   
Contact: Chen Jianwen    18036611985    chenjianwen@hrglobe.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04390295    
Other Study ID Numbers: SHR3824-302
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs