Status:
COMPLETED
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06059326
Start Date
January 22 2019
End Date
November 5 2019
Last Update
September 28 2023
Active Locations (1)
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1
Peking university people's hospital
Beijing, Beijing Municipality, China, 100044