theoretical benefit has translated into clinical reductions in severe and nocturnal4 hypoglycemia events in patients with diabetes. A 47% reduction in nocturnal reactions and severe hypoglycemia was noted with the use of Insulin Lispro as compared with regular human insulin in subjects with type 1 diabetes despite use in subjects with a history of severe hypoglycemia.5 Comparable data were noted in subjects with type 2 diabetes new to insulin therapy who experienced a 24% reduction in prevalence of nocturnal hypoglycemia in those treated with Lispro.6 Similar findings have been demonstrated with insulin Aspart in both European and American trials.7
Of particular interest, investigators found the use of Ultralente insulin (the formulation utilized in UKPDS) to be associated with an increased risk of hypoglycemia.8 Not only has the availability of very rapid acting insulin reduced the risk and occurrence of hypoglycemia, but new long-acting insulin preparations have minimized hypoglycemia risk as well. In type 1 diabetes, all hypoglycemia was reduced by 43% and severe hypoglycemia by 40% with insulin Glargine as compared to intermediate-acting NPH insulin.9 A fifty percent reduction in nocturnal hypoglycemia was found in patients with type 2 diabetes treated with insulin Glargine as opposed to NPH insulin.10
Thus, the UKPDS and DCCT provided important baseline information on risks and predictability of hypoglycemia in patients who choose to seek very tight control, but newer
4 Incidence of nocturnal hypoglycemia is relevant because it tracks a long period of time in which the patient does not eat, as might be the case of a long haul driver.
Ferguson SC, Strachan MW, Janes JM, Frier BW: Severe Hypoglycaemia in Patients with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia: A Comparative Study of Insulin Lispro and Regular Human Insulin. Diabetes Metabolism Research Review 17(4):285-91 (July – Aug 2001). 5
6 Bastyr EJ III, Huang Y, Brunelle RL, Vignati, L, Cox DJ, Kotsanos JG: Factors Associated with Nocturnal Hypoglycaemia Among Patients with Type 2 Diabetes New to Insulin Therapy: Experience with Insulin Lispro. Diabetes, Obesity and Metabolism 2:39-46 (2000).
Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L: Use of Insulin Aspart, a Fast-Acting Insulin Analog, as the Mealtime Insulin in the Management of Patients with Type 1 Diabetes. Diabetes Care 2000 23: 583-588; and Heller S, Colagiuri S, Vaaler S, Wolffenbuttel B, Koelendorf K, Friberg H, Windfeld K, Sondergaard K, Linholm A: Reduced Hypoglycemia with Insulin Aspart: A Double-Blind Randomized, Crossover Trail in Type 1 Diabetic Patients. Diabetes 50(Supplement 2): A137 (2001) (abstract). 7
8 Bastyr EJ III, Huang Y, Brunelle RL, Vignati, L, Cox DJ, Kotsanos JG: Factors Associated with Nocturnal Hypoglycaemia Among Patients with Type 2 Diabetes New to Insulin Therapy: Experience with Insulin Ispro. Diabetes, Obesity and Metabolism 2:39-46 (2000).
9 Ratner R, Hirsch E, Neifing J, Garg S, Mecca T, Wilson C: Less Hypoglycemia with Insulin Glargine in Intensive Insulin Therapy for Type 1 Diabetes. Diabetes Care 23:639 (2000).
10 Yki-Jarvinen H, Dressler A, Zeimen M: Less Nocturnal Hypoglycemia and Better Post-Dinner Glucose Control with Bedtime Insulin Glargine Compared with Bedtime NHP Insulin During Insulin Combination Therapy in Type 2 Diabetes. Diabetes Care 23:1130-36 (2000).