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Not Yet Recruiting
NCT05677334
Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM
Conditions: Type2diabetes
Sex: All
Ages: 20 Years – 70 Years
Phase: PHASE4
Enrollment: 200
Sponsor: First Affiliated Hospital of Guangxi Medical University
Location: China
Summary
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
Eligibility Criteria
Inclusion Criteria:Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 yearsAge between 20 and 70 yearsContinuous use of any hypoglycemic drug ≤ 7 days within 6 months9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/LBody mass index (BMI) of between 18 and 28 kg/m2Be able to understand the contents and methods of this study and sign the informed consent form voluntarilyExclusion Criteria:Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complicationsUrinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection historySerious trauma or acute infection occurred within 4 weeks that may affect blood glucose controlPeople 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 monthsSerious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)Uncontrolled hyperthyroidismThose who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperatePregnant or lactating womenALT>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
Source: ClinicalTrials.gov (NCT05677334). StuddyBuddy aggregates publicly available trial information.