RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes (RABBIT 2 Trial)

Abstract

Background: Few studies have focused on the optimal management of hyperglycemia in non-ICU patients with type 2 diabetes mellitus.

Research Design and Methods: Prospective, multicenter randomized trial to compare the efficacy and safety of a basal/bolus insulin regimen to sliding scale regular insulin (SSI) in patients with type 2 diabetes. A total of 130 insulin-naïve patients were randomized to receive glargine and glulisine (n= 65) or a standard SSI protocol (n= 65). Glargine was given once daily and glulisine before meals at a starting dose of 0.4 U/kg/day for BG 140-200 mg/dL or 0.5 U/kg/day for BG 201-400 mg/dL. SSI was given 4 times/day for BG >140 mg/dL.

Results: The mean admission blood glucose was 229 ± 6 mg/dL and hemoglobin A1C was 8.8 ± 2 %. A blood glucose target of < 140 mg/dl was achieved in 66% of patients in the glargine and glulisine group and 38% in the SSI. The mean daily blood glucose between groups ranged from 23 to 58 mg/dl, with an overall blood glucose difference of 27 mg/dL (p<0.01). Despite increasing insulin doses, 14% of patients treated with SSI remained with blood glucose > 240 mg/dl. There were no differences in the rate of hypoglycemia or length of hospital stay.

Conclusion: Treatment with insulin glargine and glulisine resulted significant improvement in glycemic control compared to the use of SSI alone. Our study indicates that a basal/bolus insulin regimen is preferred over SSI in the management of noncritically-ill, hospitalized patients with type 2 diabetes.

NCT registration Number: 00394407