Hypoglycemia is a major factor preventing patients with both type 1 and type 2 diabetes from achieving near-normal glycemia. The risk of hypoglycemia in diabetic patients is due to both the imperfect pharmacokinetics of current therapy that produces inappropriately high insulin concentrations and a failure in the physiological protective mechanism that limits the decrease in blood glucose concentrations. Hypoglycemia occurs as a result of good metabolic control and is a limiting factor in achieving the highest possible value in the daily glycemic profile, in every condition in which it is required.