Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: HSK7653 10 mgDrug: HSK7653 25 mgDrug: HSK7653 50 mgDrug: Placebo
- Registration Number
- NCT06059326
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Brief Summary
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HSK7653 10 mg HSK7653 10 mg - HSK7653 25 mg HSK7653 25 mg - HSK7653 50 mg HSK7653 50 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
- Secondary Outcome Measures
Name Time Method Change from baseline in GLP-1 Day 1 to Day 84 Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653
Peak plasma concentration (Cmax) of HSK7653 Day 1 to Day 43 Cmax of HSK7653 after first dose and multi-dose administration
Area under the plasma concentration versus time curve (AUC) of HSK7653 Day 1 to Day 43 AUC of HSK7653 after first dose and multi-dose administration
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate Day 1 to Day 84 Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653
Change from baseline of fasting plasma glucose Day 1 to Day 84 Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653
Change from baseline of HbA1c Day 1 to Day 84 Change from baseline in HbA1c after multi-dose administration of HSK7653
Half-life (t1/2) of HSK7653 Day 1 to Day 43 T1/2 of HSK7653 after single-dose and multi-dose administration
Trial Locations
- Locations (1)
Peking university people's hospital
🇨🇳Beijing, Beijing, China