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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: HSK7653 10 mg; Drug: HSK7653 25 mg; Drug: HSK7653 50 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablet, 0 mg Q2W, 12 weeks
Experimental: HSK7653 10 mg	Drug: HSK7653 10 mg; Tablet, HSK7653 10 mg Q2W, 12 weeks
Experimental: HSK7653 25 mg	Drug: HSK7653 25 mg; Tablet, HSK7653 25 mg Q2W, 12 weeks
Experimental: HSK7653 50 mg	Drug: HSK7653 50 mg; Tablet, HSK7653 50 mg Q2W, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of HSK7653	Cmax of HSK7653 after first dose and multi-dose administration	Day 1 to Day 43
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
Half-life (t1/2) of HSK7653	T1/2 of HSK7653 after single-dose and multi-dose administration	Day 1 to Day 43
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
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
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
Change from baseline of HbA1c	Change from baseline in HbA1c after multi-dose administration of HSK7653	Day 1 to Day 84

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): November 5, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HSK7653-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No