Clinical trial
A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes
Name
HSK7653-301
Description
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.
Trial arms
Trial start
2020-09-29
Estimated PCD
2022-01-10
Trial end
2022-08-08
Status
Completed
Phase
Early phase I
Treatment
HSK7653 10 mg Q2W
HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
Arms:
HSK7653 10 mg
HSK7653 25 mg Q2W
HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
Arms:
HSK7653 25 mg
Placebo
Placebo 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
Arms:
Placebo
Size
476
Primary endpoint
HbA1c change from baseline at week 24
Baseline and week 24
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 476, 'type': 'ACTUAL'}}
Updated at
2022-12-12
1 organization
2 products
2 indications
Organization
Sichuan Haisco Pharmaceutical GroupProduct
HSK7653Indication
Diabetes MellitusIndication
Type 2Product
Placebo