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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Placebo

SHR3824

metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Third Affiliated Hospital of Sun Yat - sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

SHR3824+Metformin, Placebo+Metformin

SHR3824 5 mg+Metformin

SHR3824 10 mg+Metformin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adjusted Mean Change in HbA1c Levels

Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04390295

First Posted

September 18, 2018

Last Updated

May 14, 2020

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04390295

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2, 2017 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR3824+Metformin, Placebo+Metformin

Arm Type

Experimental

Arm Description

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

Arm Title

SHR3824 5 mg+Metformin

Arm Type

Experimental

Arm Description

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

Arm Title

SHR3824 10 mg+Metformin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Once daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

SHR3824

Intervention Description

Once daily, 52 weeks

Intervention Type

Drug

Intervention Name(s)

metformin

Intervention Description

Three times daily, 52 weeks

Primary Outcome Measure Information:

Title

Adjusted Mean Change in HbA1c Levels

Description

Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group

Time Frame

Baseline to Week 24

Secondary Outcome Measure Information:

Title

Adjusted Mean Change in Fasting Plasma Glucose

Description

Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group

Time Frame

Baseline to Week 24

Title

The number of volunteers with adverse events as a measurement of safety

Description

Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

WENG Jianping, professor

Phone

86-020-85250217

wjianp@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

CHEN Jianwen, professor

Phone

18036611985

chenjianwen@hrglobe.cn

Facility Information:

Facility Name

Third Affiliated Hospital of Sun Yat - sen University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weng Jianping, professor

Phone

86-(20)85253239

wjianp@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Chen Jianwen

Phone

18036611985

chenjianwen@hrglobe.cn

12. IPD Sharing Statement

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

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