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The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

SHR3824

Placebo

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;
Hemoglobin A1c levels >=7.5% and <=10.5%;
Body mass index (BMI) 25 to 45 kg/m2;
Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

SHR3824 Placebo

SHR3824 5 mg

SHR3824 10 mg

SHR3824 20 mg

Arm Description

SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Outcomes

Primary Outcome Measures

Adjusted Mean Change in HbA1c Levels

The number of volunteers with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Adjusted Mean Change in Fasting Plasma Glucose

Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

Full Information

NCT ID

NCT02366377

First Posted

February 12, 2015

Last Updated

February 18, 2015

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02366377

Brief Title

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

Official Title

An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

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 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR3824 Placebo

Arm Type

Experimental

Arm Description

SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Arm Title

SHR3824 5 mg

Arm Type

Experimental

Arm Description

SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Arm Title

SHR3824 10 mg

Arm Type

Experimental

Arm Description

SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Arm Title

SHR3824 20 mg

Arm Type

Experimental

Arm Description

SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Intervention Type

Drug

Intervention Name(s)

SHR3824

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Metformin

Primary Outcome Measure Information:

Title

Adjusted Mean Change in HbA1c Levels

Time Frame

Baseline to Week 12

Title

The number of volunteers with adverse events as a measure of safety and tolerability

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

Adjusted Mean Change in Fasting Plasma Glucose

Time Frame

Baseline to Week 12

Title

Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

Time Frame

Baseline to Week 12

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; Hemoglobin A1c levels >=7.5% and <=10.5%; Body mass index (BMI) 25 to 45 kg/m2; Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day. 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).

12. IPD Sharing Statement

Learn more about this trial

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

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