Study on the Efficacy and Safety of Henagliflozin Combined With Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System

2022-K148-01

The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes

2023-03-01

2024-07-01

2024-08-01

Recruiting

Early phase I

200

Inclusion Criteria: 1. Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years 2. Age between 20 and 70 years 3. Continuous use of any hypoglycemic drug ≤ 7 days within 6 months 4. 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L 5. Body mass index (BMI) of between 18 and 28 kg/m2 6. Be able to understand the contents and methods of this study and sign the informed consent form voluntarily Exclusion Criteria: 1. Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications 2. Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history 3. Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control 4. People with negligent compensatory heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, serious arrhythmia, cardiac surgery or vascular reconstruction within 6 months 5. Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia) 6. Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) 7. Uncontrolled hyperthyroidism 8. Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate 9. Pregnant or lactating women 10. ALT\>3.0x ULN and/or AST\>3.0x ULN and/or Tbil\>2.0x ULN Blood ketone body\>ULN eGFR\<30ml/min/1.73 m2 Blood creatine kinase\>3.0x ULN

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-05-09