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HSK7653 in Chinese Patients With Impaired Glucose Tolerance

Primary Purpose

Impaired Glucose Tolerance

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HSK7653 10mg Q2W

HSK7653 25mg Q2W

Placebo

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes

Eligibility Criteria

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

Inclusion Criteria:

Impaired glucose tolerance;
BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;

Exclusion Criteria:

History of diabetes mellitus;
History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
Current uncontrolled hypertension, serious nephropathy prior to informed consent;
Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
Serious gastrointestinal disease within 2 weeks prior to informed consent;
Serious infection, trauma, and surgery within 3 months prior to informed consent;
History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;
Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
Active infectious diseases;
Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
Women who are nursing or pregnant, or subjects with birth plans;
Other protocol-defined inclusion/exclusion criteria.

Sites / Locations

Emergency General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

HSK7653 10 mg

HSK7653 25 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.

Secondary Outcome Measures

Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Change From Baseline in Fasting Glucose at Week 12

Change From Baseline in Fasting Insulin at Week 12

Change From Baseline in Fasting C-peptide at Week 12

Change From Baseline in HOMA-IS at Week 12

Change From Baseline in HOMA-β at Week 12

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10

Incidence of Treatment-Emergent Adverse Events

Full Information

NCT ID

NCT04727580

First Posted

January 21, 2021

Last Updated

April 11, 2021

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04727580

Brief Title

HSK7653 in Chinese Patients With Impaired Glucose Tolerance

Official Title

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients With Impaired Glucose Tolerance

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 29, 2021 (Actual)

Primary Completion Date

June 21, 2022 (Anticipated)

Study Completion Date

June 28, 2022 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance

Keywords

Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HSK7653 10 mg

Arm Type

Experimental

Arm Title

HSK7653 25 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

HSK7653 10mg Q2W

Intervention Description

HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12

Intervention Type

Drug

Intervention Name(s)

HSK7653 25mg Q2W

Intervention Description

HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Primary Outcome Measure Information:

Title

Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in Fasting Glucose at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in Fasting Insulin at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in Fasting C-peptide at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in HOMA-IS at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in HOMA-β at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Time Frame

Baseline and Week 12

Title

Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10

Time Frame

Baseline and Week 10

Title

Incidence of Treatment-Emergent Adverse Events

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Impaired glucose tolerance; BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening; Exclusion Criteria: History of diabetes mellitus; History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent; Current uncontrolled hypertension, serious nephropathy prior to informed consent; Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent; Serious gastrointestinal disease within 2 weeks prior to informed consent; Serious infection, trauma, and surgery within 3 months prior to informed consent; History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor; Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent; Hemoglobin (HGB) < 10.0 g/dL(100 g/L); Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent; Active infectious diseases; Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent; Women who are nursing or pregnant, or subjects with birth plans; Other protocol-defined inclusion/exclusion criteria.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fangqiong Li

Phone

+8602867258840

lifangq@haisco.com

Facility Information:

Facility Name

Emergency General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100028

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongmei Li

Phone

+8613911151692

lihongmei64@163.com

12. IPD Sharing Statement

Plan to Share IPD

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HSK7653 in Chinese Patients With Impaired Glucose Tolerance

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