RABBIT Trial

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Gerald    on May 14, 2011 Says :

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Slide 1 : Umpierrez GE et al. Diabetes Care 2007;30:2181-2186.
Slide 2 : Inpatient Hyperglycemia A common finding in hospitalized patients, even those without a previous history of diabetes Associated with increased inhospital complications, length of hospital stay and mortality Improved glycemic control reduces risk of MOF, serious infection, and mortality Umpierrez G et al, J Clin Endocrinol Metabol 87:978, 2002, Krinsley JS. Mayo Clin Proc. 2003;78:1471-1478, Van-Den Berge et al, NEJM 345:1359, 2001, Van-Den Berge et al, NEJM 354:449-61, 2006
Slide 3 : Glycemic Control in Non-ICU Settings Few prospective randomized clinical trials in general medicine/surgical services Fear of hypoglycemia and lack of established treatment algorithms in non-ICU areas leads to: Holding patient’s diabetic regimen Reliance on “sliding scale” insulin regimens Delayed starting basal/bolus insulin therapy Basal and nutritional insulin use is advocated as preferred insulin regimen Umpierrez et al, J Hospital Medicine, 1:143-144, 2006; Clement el al. Diabetes Care 27:553-591, 2004; Umpierrez et al, Am J Med, 120:563-567, 2007.
Slide 4 : Methods for Managing Hospitalized Persons With Diabetes ICU: Continuous variable-rate IV insulin drip Non-ICU: Basal/bolus therapy (MDI) NPH and regular insulin Long-acting and rapid-acting insulin Sliding scale short-acting insulin
Slide 5 : 5 Glycemic Control in Non-ICU Settings Conventional Insulin Rx Limitations B L S HS B Reg NPH Insulin Effect Meals NPH Reg Lacks flexibility Poor match between regular insulin and meals - Initial hyperglycemia - Late hypoglycemia Fasting hyperglycemia
Slide 6 : 6 Sliding-scale insulin concerns: Reactive approach: ? Hyperglycemia Insulin stacking: ? Hypoglycemia Sliding-Scale Regular Insulin Adapted from the following sources: DeWitt DE, Dugdale DC. JAMA. 2003;289:2265-2269; Skyler JS. In: DeFronzo RA, ed. Current Therapy of Diabetes Mellitus.1998.
Slide 7 : 7 MDIs of Insulin Glargine QD + Rapid-acting Analog AC 21:00 18:00 Breakfast Lunch Dinner 12:00 8:00 Time Glargine Insulin Action
Slide 8 : Objectives To determine whether inpatient glycemic control, as measured by mean daily BG, is different between insulin glargine once daily plus glulisine before meals versus SSRI four-times daily in patients with type 2 diabetes To determine the safety of a basal bolus insulin regimen vs. SSRI
Slide 9 : Methods 130 insulin-naïve diabetic subjects Inclusion Criteria: Age 18 – 80 yrs Known history of type 2 DM > 3 months BG > 140 mg/dL and < 400mg/dL Previous Rx: diet alone or diet + OADs
Slide 10 : Exclusion Criteria New Onset or undiagnosed diabetes DKA or HHNS Preadmission insulin use Admission to MICU or SICU Use of glucocorticoids Creatinine > 3 mg/dl Mental illness or incompetence HIV Pregnancy or lactation
Slide 11 : Measured Outcomes Differences in glycemic control as measured by mean daily BG 2) Differences between treatment groups in the following measures: - number of hypoglycemic events (< 60 mg/dl) - number of severe hyperglycemia (> 300 mg/dl) - length of hospital stay - mortality
Slide 12 : Basal–Bolus Insulin Regimen D/C oral antidiabetic drugs on admission Starting total daily dose (TDD): 0.4 U/kg/d x BG between 140-200 mg/dL 0.5 U/kg/d x BG between 201-400 mg/dL Half of TDD as insulin glargine (Lantus®) and half as glulisine (Apidra®) Insulin glargine - once daily, at the same time of the day. Insulin glulisine - three equally divided doses (AC)
Slide 13 : Hyperglycemia (FPG >140 mg/dL) without hypoglycemia, increase glargine dose by 20% Hypoglycemia (BG < 60 mg/dL), decrease glargine dose by 20% Consider using the total supplemental dose, nutritional intake, and results of BG to adjust insulin regimen Insulin Dose Adjustment
Slide 14 : SSRI Regimen
Slide 15 : Characteristics of Enrolled Subjects
Slide 16 : Umpierrez et al, Diabetes Care 30:2181–2186, 2007
Slide 17 : Treatment success BG target of < 140 mg/dL was achieved in 66% of patients on Basal-Bolus (Lantus® + Apidra®) and 38% regular insulin (SSI) Treatment failure One out of 5 patients using SSI remained with BG >240 mg/dL and switched to Basal-Bolus (Lantus® + Apidra®) Adapted from Umpierrez GE et al. Diabetes Care. 2007;30:2181-2186. Days of Therapy Blood Glucose (mg/dL) 100 120 140 160 180 200 220 240 Admit 1 2 3 4 1 2 3 4 5 6 7 Sliding-ScaleInsulin Delivery LANTUS® + APIDRA® 260 280 300 Sliding-ScaleInsulin Basal-Bolus Basal–Bolus Insulin Regimen in Noncritically Ill Patients
Slide 18 : Difference Between groups (mg/dL) 18 23 35 41 40 58 39 44 34 37 Mean Blood Glucose Levels in Patients Treated with Basal Bolus and SSRI
Slide 19 : RABBIT-2 Trial: Insulin Dose The mean daily insulin dose was significantly higher in the basal-bolus group than in the SSI group Umpierrez GE et al. Diabetes Care 2007;30:2181-2186.
Slide 20 : Hypoglycemia Basal Bolus Group: 1,005 BG readings Two patients (3%) had BG < 60 mg/dL Four BG readings (0.4%) < 60 mg/dL No BG < 40 mg/dL SSRI: 1,021 BG readings Two patients (3%) had BG < 60 mg/dL Two BG readings (0.2%) < 60 mg/dL No BG < 40 mg/dL None of the episodes of hypoglycemia in either group were associated with adverse outcomes
Slide 21 : Summary This RCT indicates that the use of basal-bolus is a better regimen than SSRI for glycemic control in non-ICU patients with type 2 diabetes Mean daily BG difference between groups ranged from 23 to 58 mg/dl during days 2 to 6 of therapy, with an overall blood glucose difference of 27 mg/dL A glucose target of < 140 mg/dL was achieved in 2/3 of patients treated with glargine and glulisine but only in 1/3 of those treated with SSR
Slide 22 : Summary Despite increasing insulin doses, 14% of patients treated with SSRI had persistently elevated BG > 240 mg/dL In such patients, glycemic control rapidly improved achieving the glucose target of < 140 mg/dL after switching to the basal/bolus regimen
Slide 23 : Summary The use of the basal/bolus insulin regimen was safe and was associated with a low rate of hypoglycemic events The overall rate of hypoglycemia (< 60 mg/dL) occurred in 3% of patients in both treatment groups and none were associated with clinical adverse outcome There were no episodes of severe hypoglycemia (glucose < 40 mg/dL) in either treatment group
Slide 24 : Conclusion Basal/bolus insulin regimen with glargine once daily and glulisine before meals is a better insulin regimen than SSRI in the management of type 2 diabetics in the non-ICU setting. SSRI as a single insulin regimen should not be used for the management of patients with type 2 diabetes.
Slide 25 : Acknowledgements Funding: Sanofi-Aventis

 


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