Clinical trial NCT04556851: HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: T2DM
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 476
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: The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.

Detailed description: The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label period, all participants will receive 25 mg dose of HSK7653.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years, Male and female patients;
* Type 2 diabetes mellitus;
* Control the blood glucose level only with diet and exercise in last 8 weeks;
* Did not receive regular long-term medication of oral hypoglycemic drugs or insulin within 1 year prior to informed consent;
* HbA1c in the range of ≥7.5 to ≤11.0% at screening;
* FPG \< 15 mmol/L at screening;
* BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.

Exclusion Criteria:

* Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
* History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
* Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy 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 Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
* 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;
* Contraindication for metformin;
* Other protocol-defined inclusion/exclusion criteria.

Primary outcomes:
measure: HbA1c change from baseline at week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: The Safety of HSK7653 at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients With HbA1c <7.0%
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients With HbA1c <6.5%
timeFrame: Baseline, week 24 and week 52
measure: FPG Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: 2h-PPG Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Weight Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Fasting C-peptide Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Pancreatic β-cell function Change (Calculated by HOMA-β ) From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia
timeFrame: Baseline, week 24 and week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Zhujiang
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: