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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Drug-drug Interaction of SHR3824 and Metformin

NCT02354027

Type 2 Diabetes

COMPLETED PHASE1

the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin

NCT02438397

Type 2 Diabetes

UNKNOWN PHASE4

A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects

NCT05108350

Type II Diabetes

UNKNOWN PHASE1

A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

NCT00871936

Type 2 Diabetes

COMPLETED PHASE2

Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

NCT03349684

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SHR3824+Metformin, Placebo+Metformin

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Once daily, 24 weeks

SHR3824 5 mg+Metformin

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

Once daily, 52 weeks

metformin

Intervention Type DRUG

Three times daily, 52 weeks

SHR3824 10 mg+Metformin

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

Once daily, 52 weeks

metformin

Intervention Type DRUG

Three times daily, 52 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Once daily, 24 weeks

Intervention Type DRUG

SHR3824

Once daily, 52 weeks

Intervention Type DRUG

metformin

Three times daily, 52 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No