Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
- Registration Number
- NCT02346175
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- BMI:20-35kg/m2;
- Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
- On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
- Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.
Exclusion Criteria
- History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
- Pregnancy or breastfeeding;
- Significant acute or chronic medical illness, including renal impairment, or recent surgery;
- Donation of blood or plasma within the 4 weeks prior to the start of the study;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort1 Placebo 5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. Cohort2 SHR3824 10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. Cohort3 Placebo 20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. Cohort3 SHR3824 20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. Cohort2 Placebo 10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10. Cohort1 SHR3824 5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
- Primary Outcome Measures
Name Time Method Urine glucose concentration of SHR3824 up to Day 11 Plasma pharmacokinetic parameters of SHR3824 up to Day 13 Plasma glucose concentration of SHR3824 up to Day 11
- Secondary Outcome Measures
Name Time Method The number and type of adverse events reported Up to Day 13