Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that results from the RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery (RABBIT-2 Surgery) found that treatment with a basal-bolus regimen that included Lantus® (insulin glargine [rDNA origin] injection) once-daily and Apidra® (insulin glulisine [rDNA origin] injection) before meals improved glycemic control and reduced hospital complications, compared to "sliding scale" insulin (SSI) in general surgery patients with type 2 diabetes. The study results were presented at the American Diabetes Association's 70th Annual Scientific Sessions.
Basal-bolus insulin regimens are designed to address hyperglycemia before it happens by providing adequate insulin to cover fasting and prandial insulin needs, while SSI regimens provide a corrective dose of insulin after the development of hyperglycemia has occurred.
"Hyperglycemia in hospitalized patients is a common and costly health care problem for patients living with type 2 diabetes," said Guillermo E. Umpierrez, MD, Professor of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine and lead author of this investigator-sponsored study. "This study indicates that a basal-bolus insulin regimen consisting of Lantus® and Apidra® may be an effective insulin regimen in the hospital management of general surgery patients with type 2 diabetes."
The primary endpoint of glycemic control was measured by differences in daily blood glucose (BG) levels and the secondary endpoint was a composite of postoperative complications including wound infection, pneumonia, respiratory failure, acute renal failure, and bacteremia. A blood glucose of < 70 mg/dl was reported in 23.1% of patients in the Lantus® and Apidra® group versus 4.7% of patients in the SSI group (p<0.001), but there were no significant differences in the frequency of severe hypoglycemia (blood glucose < 40 mg/dl) between groups>
RABBIT-2 Surgery Study Results
This randomized multicenter trial compared the efficacy and safety of Lantus® and Apidra® in a basal-bolus regimen to SSI in non-ICU patients undergoing general surgery. A total of 211 patients were randomized to Lantus® and Apidra®>
- The percentage of BG readings <140mg/dl were higher in the Lantus® and Apidra® group than the SSI (53+/-30% versus 31+/-28%, p<0.001)
- There was a significant difference between groups in the frequency of the composite outcome (24.3% and 8.6% in the SSI and Lantus® and Apidra® groups, respectively,>
- Reductions in wound infection (2.9% versus 10.3%,>
- Reductions in ICU length of stay (3.2+/-2 versus 1.2+/-0.6 days,>
- No differences in mortality (1% versus 1%)