RABBIT Trial Ppt Powerpoint Presentation slides Guillermo Umpierrez Medical Slideshow 9,800 Oncology trials 9,000 CNS trials 8,900 Anti infective trials 4,500

RABBIT Trial

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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

	geumpie@emory.edu 1 Years ago. Category: Internal Medicine

Tags:	Internal Medicine

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