NCT05677334CompletedPhase 4
Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (actual)
- First submitted
- 22 Dec 2022
- Start date
- Mar 2023
- Primary completion date
- Oct 2024
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05677334
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 210
- From Mar 2023 to the primary completion date, Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)
Other illness
- Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history
- 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
- Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)
- Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate
Lab values
- Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control
- 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
Other
- Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications
- Uncontrolled hyperthyroidism
- Pregnant or lactating women
Who the study is looking for
- Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years
- Age between 20 and 70 years
- Continuous use of any hypoglycemic drug ≤ 7 days within 6 months
- 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L
- Body mass index (BMI) of between 20 and 32 kg/m2
- Be able to understand the contents and methods of this study and sign the informed consent form voluntarily
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.