Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes (RABBIT 2 Trial)

Abstract

OBJECTIVE -We sought to study the optimal management of hyperglycemia in nonintensive care unit patients with type 2 diabetes, as few studies thus far have focused on the subject.RESEARCH DESIGN AND METHODS -We conducted a prospective, multicenter, randomized trial to compare the efficacy and safety of a basal-bolus insulin regimen with that of sliding-scale regular insulin (SSI) in patients with type 2 diabetes. A total of 130 insulin-naive patients were randomized to receive glargine and glulisine (n ϭ 65) or a standard SSI protocol (n ϭ 65). Glargine was given once daily and glulisine before meals at a starting dose of 0.4 units ⅐ kg Ϫ1 ⅐ day Ϫ1 for blood glucose 140 -200 mg/dl or 0.5 units ⅐ kg Ϫ1 ⅐ day Ϫ1 for blood glucose 201-400 mg/dl. SSI was given four times per day for blood glucose Ͼ140 mg/dl. RESULTS -The mean admission blood glucose was 229 Ϯ 6 mg/dl and A1C 8.8 Ϯ 2%. A blood glucose target of Ͻ140 mg/dl was achieved in 66% of patients in the glargine and glulisine group and in 38% of those in the SSI group. 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 Ͻ 0.01). Despite increasing insulin doses, 14% of patients treated with SSI remained with blood glucose Ͼ240 mg/dl. There were no differences in the rate of hypoglycemia or length of hospital stay.CONCLUSIONS -Treatment with insulin glargine and glulisine resulted in significant improvement in glycemic control compared with that achieved with the use of SSI alone. Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the management of non-critically ill, hospitalized patients with type 2 diabetes. Diabetes Care 30:2181-2186, 2007H yperglycemia in hospitalized patients is a common, serious, and costly health care problem with profound medical consequences. Increasing evidence indicates that the development of hyperglycemia during acute medical or surgical illness is not a physiologic or benign condition but is a marker of poor clinical outcome and mortality (1-3). Extensive evidence from observational studies, including our own, indicates that in hospitalized patients with critical illness, hyperglycemia is associated with an increased risk of complications and mortality (3-9). Prospective randomized trials in critically ill patients have shown that intensive glucose control reduces the risk of multiorgan failure, systemic infections, and short-and longterm mortality. Effective management of hyperglycemia is also associated with a decreased length of intensive care unit and hospital stay (4,6,8 -10) and decreased total hospitalization cost (11). The importance of glycemic control on outcome is not limited to patients in critical care areas but also applies to patients admitted to general surgical and medical wards. In such patients, the presence of hyperglycemia has been associated with prolonged hospital stay, infection, disability after hospital discharge, and death (1,5,12). In general surgery patients, the relative risk for serious postopera...

Evaluation of glycemic control following discontinuation of an intensive insulin protocol

“…In fact, hyperglycemia has been associated with prolonged hospital stay, infection, disability after discharge, and death in patients on general surgical and medical wards. [10][11][12] This makes the increase in mean BG found in our study following discontinuation of the IIP a concern.…”

“…Umpierrez et al 12 conducted a prospective, multicenter randomized trial to compare the efficacy and safety of a basal-bolus insulin regimen with that of SSI in hospitalized type 2 diabetics. These authors found that patients treated with insulin glargine and glulisine had greater improvement in glycemic control than those treated with SSI (P < 0.01).…”

Evaluation of hospital glycemic control at US Academic Medical Centers

“…A recent prospective randomized clinical trial demonstrated superior glycemic control in non-critically ill hospitalized patients with type 2 diabetes with basal/bolus insulin therapy compared to sliding scale insulin alone. 31 Use of basal/bolus insulin regimens as part of a comprehensive hospital diabetes management program has been shown to improve glycemic control in an academic medical center. 20 Therefore, we do not believe that our regression analysis findings invalidate the concept of basal/ bolus insulin for inpatients with hyperglycemia, but rather indicate the need for more research into subcutaneous insulin regimens and hospital care practices that lead to improved glucose control.…”

Management of diabetes and hyperglycemia in the hospital: A practical guide to subcutaneous insulin use in the non-critically ill, adult patient

“…9,10 A recent randomized, controlled trial demonstrated that a physiologic insulin regimen is indeed superior to a standardized insulin sliding-scale for managing inpatient hyperglycemia. 4 Ms. X should be given an insulin regimen that includes basal, nutritional, and correctional components. The provision of separate basal and nutritional insulin will allow the clinicians to provide the patient with basal insulin even when her nutritional insulin is held, and to easily modify her nutritional insulin, depending on her nutritional intake.…”

“…This approach has been disseminated via review articles, 3 and more recently, a randomized, controlled trial demonstrated that hospitalized type 2 diabetes patients experienced better glycemic control when treated with a physiologic insulin regimen than when treated with sliding-scale insulin alone. 4 The Society of Hospital Medicine has assembled a Glycemic Control Task Force, which is charged with providing physicians and hospitals with practical tools to improve the safety and efficacy of diabetes management in the hospital. One product of this work is an educational module that serves as a tutorial on the best practice for the management of diabetes and hyperglycemia in the noncritically ill hospital patient.…”