20-PUB: Intensification of Human Insulin Therapy with SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus

Treatment intensification with SGLT2 inhibitors added to insulin therapy is recommended in many T2DM guidelines as well as registered indications. The aim of the study was the assessment of the efficacy and safety of SGLT2 inhibitors with human insulin combinations in comparison with the general treatment options in T2DM patients onwith human insulins therapy. The data were collected in non-interventional multicenter observational open label study recruiting 4384 T2DM patients treated with human insulin (Gensulin®) injected with the same device (Gensupen®2 ). Combinations including SGLT2 inhibitors was observed in 1079 (24,6%). Triple combination of human insulin+metformin+SGLT2 inhibitors was the most commonly used (632 patients, 14,4%). SGLT2 inhibitors treatment intensification was found in 40,1% of patients with diagnosed HF (those with HFrEF in 59,65%), history of MI 40,4% and CKD in 30,25%. Patients age, gender, BMI nor history of stroke did not affect the frequency of SGLT2 inhibitors use. The decrease of A1c in 6 months observation period in SGLT2 group was 0,8% while 0,7% in the general treatment group. A1c after 6 months was similar in both groups (7,7% and 7,8%). The percentage of patients achieving target A1c less than 7% was also similar ( 5,6% and 21,3% after 6 months vs. 5,8% and 18,9% respectively). Median insulin daily dose didn’t differ between groups (35,2U vs 34U ) as well as insulin dose per kg (0,4U/kg vs.0,4U/kg) at the study end. The confirmed hypoglycaemia rate was very low and did not differ between groups as well as percentage of patients not reporting hypogylaemia in 6 month period ( 82,7% vs. 84%). The intensification of human insulin treatment in T2DM patients with SGLT2 inhibitors did not affect significantly glucose control efficacy and safety. HF, history of MI and CKD were the strongest indications for SGLT2 inhibitors choice. The optimalization of insulin dose seems to be a crucial intervention needed to achieve appropriate glucose control.