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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HSK7653 10 mg
HSK7653 25 mg
HSK7653 50 mg
Placebo
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking university people's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HSK7653 10 mg

HSK7653 25 mg

HSK7653 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.

Secondary Outcome Measures

Peak plasma concentration (Cmax) of HSK7653
Cmax of HSK7653 after first dose and multi-dose administration
Area under the plasma concentration versus time curve (AUC) of HSK7653
AUC of HSK7653 after first dose and multi-dose administration
Half-life (t1/2) of HSK7653
T1/2 of HSK7653 after single-dose and multi-dose administration
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
Change from baseline in GLP-1
Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653
Change from baseline of fasting plasma glucose
Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653
Change from baseline of HbA1c
Change from baseline in HbA1c after multi-dose administration of HSK7653

Full Information

First Posted
September 23, 2023
Last Updated
September 23, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06059326
Brief Title
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HSK7653 10 mg
Arm Type
Experimental
Arm Title
HSK7653 25 mg
Arm Type
Experimental
Arm Title
HSK7653 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HSK7653 10 mg
Intervention Description
Tablet, HSK7653 10 mg Q2W, 12 weeks
Intervention Type
Drug
Intervention Name(s)
HSK7653 25 mg
Intervention Description
Tablet, HSK7653 25 mg Q2W, 12 weeks
Intervention Type
Drug
Intervention Name(s)
HSK7653 50 mg
Intervention Description
Tablet, HSK7653 50 mg Q2W, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, 0 mg Q2W, 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
Time Frame
From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Secondary Outcome Measure Information:
Title
Peak plasma concentration (Cmax) of HSK7653
Description
Cmax of HSK7653 after first dose and multi-dose administration
Time Frame
Day 1 to Day 43
Title
Area under the plasma concentration versus time curve (AUC) of HSK7653
Description
AUC of HSK7653 after first dose and multi-dose administration
Time Frame
Day 1 to Day 43
Title
Half-life (t1/2) of HSK7653
Description
T1/2 of HSK7653 after single-dose and multi-dose administration
Time Frame
Day 1 to Day 43
Title
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate
Description
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653
Time Frame
Day 1 to Day 84
Title
Change from baseline in GLP-1
Description
Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653
Time Frame
Day 1 to Day 84
Title
Change from baseline of fasting plasma glucose
Description
Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653
Time Frame
Day 1 to Day 84
Title
Change from baseline of HbA1c
Description
Change from baseline in HbA1c after multi-dose administration of HSK7653
Time Frame
Day 1 to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Peking university people's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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