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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06059326
• Other study ID #: HSK7653-201
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: September 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HSK7653 10 mg
Tablet, HSK7653 10 mg Q2W, 12 weeks
• HSK7653 25 mg
Tablet, HSK7653 25 mg Q2W, 12 weeks
• HSK7653 50 mg
Tablet, HSK7653 50 mg Q2W, 12 weeks
• Placebo
Tablet, 0 mg Q2W, 12 weeks

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.	From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Secondary	Peak plasma concentration (Cmax) of HSK7653	Cmax of HSK7653 after first dose and multi-dose administration	Day 1 to Day 43
Secondary	Area under the plasma concentration versus time curve (AUC) of HSK7653	AUC of HSK7653 after first dose and multi-dose administration	Day 1 to Day 43
Secondary	Half-life (t1/2) of HSK7653	T1/2 of HSK7653 after single-dose and multi-dose administration	Day 1 to Day 43
Secondary	Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate	Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653	Day 1 to Day 84
Secondary	Change from baseline in GLP-1	Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653	Day 1 to Day 84
Secondary	Change from baseline of fasting plasma glucose	Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653	Day 1 to Day 84
Secondary	Change from baseline of HbA1c	Change from baseline in HbA1c after multi-dose administration of HSK7653	Day 1 to Day 84