RABBIT 2
Trial question
What is the effect of basal-bolus insulin therapy in the management of non-critically ill, hospitalized patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 130
130 patients (67 female, 63 male).
Inclusion criteria: non-critically ill, hospitalized patients with T2DM who are insulin-naive.
Key exclusion criteria: without a known history of diabetes, ICU patients, the use of corticosteroid therapy, expected to undergo surgery during the hospitalization course, clinically relevant hepatic disease, serum creatinine ≥ 3.0 mg/dl, or pregnancy.
Interventions
N=65 use of a basal-bolus insulin regimen (glargine once daily and glulisine before meals at a starting dose of 0.4 units x kg(-1) x day(-1) for blood glucose 140-200 mg/dl or 0.5 units x kg(-1) x day(-1) for blood glucose 201-400 mg/dl).
N=65 use of a standard sliding-scale insulin protocol (sliding-scale regular insulin four times per day for blood glucose > 140 mg/dL).
Primary outcome
Percentage of patients achieving mean glucose target of < 140 mg/dL
66%
38%
66.0 %
49.5 %
33.0 %
16.5 %
0.0 %
Use of a basal-bolus insulin
regimen
Use of a standard sliding-scale insulin
protocol
Significant
increase ▲
NNT = 3
Significant increase in the percentage of patients achieving mean glucose target of < 140 mg/dL (66% vs. 38%; RR 1.74, 95% CI 0.42 to 3.06).
Conclusion
In non-critically ill, hospitalized patients with T2DM who are insulin-naive, use of a basal-bolus insulin regimen were superior to use of a standard sliding-scale insulin protocol with respect to the percentage of patients achieving mean glucose target of < 140 mg/dL.
Reference
Umpierrez GE, Smiley D, Zisman A et al. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6.
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