Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
Type 2 Diabetes Mellitus

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Age ≥18 and Age ≤70 years T2DM patients, Control the blood glucose level only with diet and exercise in last 3 months; BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index) HbA1c ≥7.0% and HbA1c <10.0% FPG <13.9 mmol/L Exclusion Criteria: Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history; History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis); History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening); Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months; Three or more episodes of hypoglycemia occurred in the six months prior to screening; History of hyperthyroidism within 6 months before screening; Severe cardiovascular disease. ; Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening; Liver function tests abnormal; Moderate or severe renal impairment; Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant; Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP > 160 mmHg and (or) DBP > 100 mmHg; Patients with uncontrolled hyperlipidemia.
Sites / Locations
- Peking university people's hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
HSK7653 10 mg
HSK7653 25 mg
HSK7653 50 mg
Placebo