Type2diabetes
Conditions
Keywords
Continuous subcutaneous insulin infusion, sglt2i, Continuous Glucose Monitoring, Type 2 diabetes
Brief 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
Detailed description
The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on continuous glucose monitoring system.
Interventions
DRUGHenagliflozin
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Continuous Subcutaneous Insulin Infusion therapy alone
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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 20 and 32 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose | Monitoring 5-14 days | Compare the TIR of the two treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken for TIR >70% | 5-14 days after treatment | Compare the time required for TIR \>70% of the two groups |
| Mean Amplitude of Glycemic Excursions (MAGE) | 5-14 days after treatment | Compare the mage of the two treatment groups |
| time below range (TBR) | 5-14 days after treatment | Compare the TBR of the two treatment groups |
| total insulin dosage | 5-14 days after treatment | Compare the total insulin dosage of the two treatment groups |
| time above range (TAR) | 5-14 days after treatment | Compare the TAR of the two treatment groups |
Countries
China
Outcome results
None listed