MD Conference Express ADA 2011 - (Page 19)

The objectives of the study were to 1) investigate the relationship between the BeAM factor and glycated HbA1C, fasting blood glucose, and hypoglycemia events, and 2) to identify the BeAM factor value at which patients with type 2 diabetes may no longer benefit from continued basal insulin titration, and may need the addition of prandial insulin instead. The BeAM factor is defined as the difference between bedtime and pre-breakfast fasting blood glucose. BeAM values were examined using data pooled from 6 randomized controlled trials of insulin glargine versus a comparator added to oral antidiabetic therapy in adults with type 2 diabetes. Insulin was titrated to achieve fasting glucose ≤100 mg/dL. Mean baseline characteristics of the 1699 patients in the study were 42% female, 95% white, and 59(9) (mean±SD) years of age, with an HbA1C of 8.7% and a duration of diabetes of 9(6) years. BeAM factors were calculated and analyzed at baseline and Week 24. Data were also categorized according to baseline and Week 24 BeAM factor values <40 mg/dL, ≥40 mg/dL to ≤50 mg/dL, and >50 mg/dL. Pearson’s correlation coefficient, analysis of covariance, and logistic regression were used to assess data. Analyses showed that BeAM increased over 24 weeks of treatment. Mean change was greater in patients receiving basal insulin (glargine or NPH) versus other treatments, including oral antidiabetic agents or other insulin (least square mean difference was 36.5 mg/dL; p<0.0001). Regardless of treatment, patients nearing the target fasting blood glucose ≤100 mg/dL had a greater increase in BeAM; the proportion of patients with BeAM >50 mg/dL increased from 27% at baseline to 47% at Week 24. Patients with a higher Week 24 BeAM factor experienced a higher incidence of nocturnal hypoglycemic events per year, such that the odds of a patient experiencing at least one nocturnal hypoglycemic event increased by approximately 0.3% for every 1.0 mg/dL increase in BeAM (p=0.018; Table 1). A larger BeAM at Week 24 was associated with reduced likelihood of attaining HbA1C ≤7.0% (r2=0.160 all; r2=0.187 BI; p<0.0001 for both) and increased risk of nocturnal (r2=0.152; p<0.0001), but not overall hypoglycemia. The analysis suggested that patients on basal insulin with a BeAM factor >55 mg/dL may not benefit from continued basal insulin titration and that the addition of prandial insulin should be considered to correct glucose excursions and achieve glycemic control. Most investigators who evaluate the relationship between glycemic variability and patient outcomes have used conventional variability statistics, such as standard deviation, coefficient of variation, postprandial peaks, or area under the curve.6 However, conventional methods that rely on blood glucose values to predict the risk of hyperglycemia or hypoglycemia are substantively limited in that risk is not normally distributed over the usual blood glucose scale.7 Table 1. Effect of BeAM Factor on Frequency and Yearly Rate of Symptomatic Hypoglycemia Events. Frequency of Events Week 24 BeAM Factor Total symptomatic hypoglycemia Severe hypoglycemia Glucose confirmed (<50 mg/dL) hypoglycemia Glucose confirmed (<70 mg/dL) hypoglycemia Nocturnal hypoglycemia Incremental OR (95% CI) 0.999 (0.997–1.001) 1.001 (0.994–1.009) 1.000 (0.998–1.002) 1.000 (0.998–1.002) 1.003 (1.000–1.005) p value 0.50 0.76 0.86 0.65 0.018 Yearly Event Rate Pearson's Correlation Coefficient -0.0037 0.0351 -0.0495 -0.0187 0.1523 p value 0.88 0.16 0.046 0.45 <0.0001 The increasing prevalence, variable pathogenesis, progressive natural history, and complications of type 2 diabetes underscore the need for new treatment strategies and novel approaches to glycemic regulation. Because of the variable and progressive pathophysiological changes associated with type 2 diabetes, pharmacological compounds that act in varied ways are needed at different stages of the disease.8 A quick and effective means to determine when to intensify treatment will enhance current therapies as well as those in development. References: 1. Riddle MC. Combined therapy with insulin plus oral agents: Is there any advantage? An argument in favor. Diabetes Care. 2008;31 Suppl 2:S125-130. Ampudia-Blasco FJ, Rossetti P, Ascaso JF. Basal plus basal-bolus approach in type 2 diabetes. Diabetes Technol Ther. 2011;13 Suppl 1:S75-83. Owens DR, Luzio SD, Sert-Langeron C, Riddle MC. Effects of initiation and titration of a single pre-prandial dose of insulin glulisine while continuing titrated insulin glargine in type 2 diabetes: A 6-month ‘proof-of-concept’ study. Diabetes Obes Metab. 2011;Jun 16:Epub ahead of print. Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. A comparison of two intensification regimens with rapid-acting insulin aspart in type 2 diabetes inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: The step-wise™ randomized study. Endocr Pract. 2011;6:1-26. Zisman A., Vlajnic, A, Zhou R. The BeAM Factor: An easy-to-determine, objective clinical indicator for deciding when to add prandial insulin to basal insulin in type 2 diabetes. Diabetes July 2011 60:A235-A352 (poster 1121-P). Kovatchev BP, Otto E, Cox D, Gonder-Frederick L, Clarke W. Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care. 2006;29:2433-2438. McCall AL, Cox DJ, Brodows R, Crean J, Johns D, Kovatchev B. Reduced daily risk of glycemic variability: Comparison of exenatide with insulin glargine. Diabetes Technol Ther. 2009;11:339-344. Tahrani AA, Bailey CJ, Del Prato S, Barnett AH. Management of type 2 diabetes: New and future developments in treatment. Lancet. 2011;Jun 24:Epub ahead of print. 2. 3. 4. 5. 6. 7. 8. 

Table of Contents for the Digital Edition of MD Conference Express ADA 2011

MD Conference Express ADA 2011

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