Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients

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;