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

Sponsor
Haisco Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT06059326
Collaborator
(none)
48
Enrollment
1
Location
4
Arms
9.4
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: HSK7653 10 mg
  • Drug: HSK7653 25 mg
  • Drug: HSK7653 50 mg
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 22, 2019
Actual Primary Completion Date :
Nov 5, 2019
Actual Study Completion Date :
Nov 5, 2019

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: Placebo

Drug: Placebo
Tablet, 0 mg Q2W, 12 weeks

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Peak plasma concentration (Cmax) of HSK7653 [Day 1 to Day 43]

    Cmax of HSK7653 after first dose and multi-dose administration

  2. 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

  3. Half-life (t1/2) of HSK7653 [Day 1 to Day 43]

    T1/2 of HSK7653 after single-dose and multi-dose administration

  4. 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

  5. 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

  6. 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

  7. Change from baseline of HbA1c [Day 1 to Day 84]

    Change from baseline in HbA1c after multi-dose administration of HSK7653

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking university people's hospital Beijing Beijing China 100044

Sponsors and Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haisco Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06059326
Other Study ID Numbers:
  • HSK7653-201
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 28, 2023