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

NCT02366351 | Unknown Phase 1

• 1 other identifier: SHR3824-107
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Adjusted Mean Change in HbA1c Levels

  Baseline to Week 12

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

  Baseline to Week 12

Secondary Outcomes (2)

• Adjusted Mean Change in Fasting Plasma Glucose

  Baseline to Week 12

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

  Baseline to Week 12

Study Arms (4)

SHR3824 Placebo

EXPERIMENTAL

once daily, 12 weeks

Drug: Placebo

SHR3824 5 mg

EXPERIMENTAL

once daily, 12 weeks

Drug: SHR3824

SHR3824 10 mg

EXPERIMENTAL

once daily, 12 weeks

Drug: SHR3824

SHR3824 20 mg

EXPERIMENTAL

once daily, 12 weeks

Drug: SHR3824

Interventions

SHR3824 DRUG

Once daily, 12 weeks

SHR3824 10 mg; SHR3824 20 mg; SHR3824 5 mg

Placebo DRUG

Once daily, 12 weeks

SHR3824 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

CN (1)