Efficacy and Safety of Biphasic Insulin Aspart Treatment in Hospitalized Patients with T2DM—A Real-World Study

Aim: To evaluate the efficacy and safety of biphasic insulin aspart during first 2 to 8 days of hospital admission of patients with type 2 diabetes (T2DM) for non-glycemia related medical ailments.

Methods: An open-label, non-randomized, observational, single-center study in patients with T2DM aged between 18 and 70 years at a tertiary multispecialty hospital in India. T2DM patients with capillary blood glucose (BG) between 70 mg/dl to 400 mg/dl at admission, requiring subcutaneous biphasic insulin aspart were included in this study. Insulin dosage was individualized as per the clinician’s judgement considering the clinical status, HbA1c and other co-morbidities. The primary endpoint was mean capillary BG levels at fasting, prelunch, predinner and at midnight during day 2 to day 8 of hospital stay. Secondary endpoints were frequency and severity of hypoglycemic episodes. Appropriate statistics were applied at 2-tailed p ≤0.significance.

Results: Total 2T2DM patients were included in this study. Median age was 57 years, 66.3% male and 33.7% female. Mean duration of T2DM was 9.9 years, HbA1c 7.3%, BMI 25.9 kg/m2 and hospital stay 8.9 days. The mean (SD) BG at admission was 208.5 (82.9) mg/dL and after usage of Biphasic Insulin Aspart 188.2 (45.3) mg/dL. Mean capillary BG levels at fasting, prelunch, predinner, and at midnight were 166.9 (46.7) mg/dL, 201.0 (58.8) mg/dL, 203.9 (60.1) mg/dL, and 179.0 (48.7) mg/dL respectively. BG readings that met the target BG range (140-180 mg/dL) levels were 34.6%. During the study 5.9% of patient’s experienced hypoglycemic event of which 2% were severe requiring intravenous dextrose and 3.9% were mild. There was a significant difference in BG reduction correlating with BMI, HbA1c (p =0.05).

Conclusions: Treatment with biphasic insulin aspart is observed to be effective in achieving optimal BG levels, is well-tolerated with low hypoglycemic events in patients admitted in hospital for non-glycemia related medical ailments.