Type 2 Diabetes Mellitus
Conditions
Keywords
SHR3824 Type 2 diabetes mellitus SGLT2
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.
Interventions
DRUGSHR3824
DRUGPlacebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic parameters of SHR3824 | up to Day 13 |
| Urine glucose concentration of SHR3824 | up to Day 11 |
| Plasma glucose concentration of SHR3824 | up to Day 11 |
Secondary
| Measure | Time frame |
|---|---|
| The number and type of adverse events reported | Up to Day 13 |
Outcome results
None listed