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

• Status: Completed
• Trial end date: 2019-11-05
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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.