Clinical trial NCT04727580: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Keywords: Impaired Glucose Tolerance
DPP-4 inhibitor
Prediabetes
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Glucose at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Insulin at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting C-peptide at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in HOMA-IS at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in HOMA-β at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
timeFrame: Baseline and Week 12
measure: 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
timeFrame: Baseline and Week 10
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Emergency General Hospital
state: Beijing
Study officials:
References: