899-P: Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes—A Multicenter, Randomized, Open-Label, Controlled Study

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Introduction and Objective: The use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in diabetes treatment is expanding. This study evaluated the efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion (CSII) in type 2 diabetes (T2DM) based on continuous glucose monitoring system (CGM).Methods: In this multicenter, randomized, open-Label, controlled study, 210 patients who had T2DM (glycated hemoglobin level of 9% -14% or fasting blood glucose≥11.1 mmol/L) within 5-7 days of hospitalization were randomly allocated in a 1:1 ratio to either the henagliflozin combined with CSII group or the CSII group. The primary endpoint was the time in the range (TIR) of 3.9~10.0 mmol/L blood glucose.Results: The TIR (3.9~10.0 mmol/L) was significantly higher in henagliflozin+CSII group, compared to CSII group (79.99% vs. 74.99%; estimated between-group difference, 5.79 percentage points [95% CI, 2.15 to 9.43]; P=0.005). The time required to achieve target glucose was shorter in henagliflozin+CSII group than in CSII group (Day 3 vs. Day 4). In terms of TAR and insulin dosage, henagliflozin+CSII group was significantly lower than CSII group, respectively (TAR: 19.48% vs. 25.43%, P=0.004; insulin dosage: 0.59U/kg/day vs. 0.66 U/kg/day, P = 0.009). There was no significant difference in the TBR and MAGE between the two groups (TBR 0.68% vs. 0.51%, P = 0.483; MAGE 5.39 mmol/L vs. 5.44 mmol/L, P = 0.805). Additionally, adverse events such as urinary tract infection, diabetic ketoacidosis and hypoglycemia events did not differ between the two groups.Conclusion: Addition of henagliflozin to CSII demonstrated superior glycemic control, shorter time taken to achieve the target glucose, and less insulin dosage compared to CSII in patients with T2DM. The overall safety profile of henagliflozin+CSII is consistent with CSII.

Disclosure

Z. Huang: None. Y. Wu: None. C. Tang: None. B. Yao: None. X. Xie: None. Q. Yang: None. Y. Qin: None.

Funding

China International Medical Foundation (Z-2017-26-2202-4); YLHR Diabetes Metabolism Research Fund Project).



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