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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Combination therapy of Henagliflozin and Continuous Subcutaneous Insulin Infusion
Continuous Subcutaneous Insulin Infusion therapy alone
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Time percentage (% TIR) in the range of 3.9~10.0 mmol/L blood glucose
Compare the TIR of the two treatment groups
Time frame: Monitoring 5-14 days
Time taken for TIR >70%
Compare the time required for TIR \>70% of the two groups
Time frame: 5-14 days after treatment
Mean Amplitude of Glycemic Excursions (MAGE)
Compare the mage of the two treatment groups
Time frame: 5-14 days after treatment
time below range (TBR)
Compare the TBR of the two treatment groups
Time frame: 5-14 days after treatment
total insulin dosage
Compare the total insulin dosage of the two treatment groups
Time frame: 5-14 days after treatment
time above range (TAR)
Compare the TAR of the two treatment groups
Time frame: 5-14 days after treatment
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