Novel drug delivery systems for insulin: clinical potential for use in the elderly.

Diabetes mellitus is a very common disease in the elderly and its complications are responsible for excess morbidity/mortality, loss of independence and impaired quality of life. Recent studies, while not performed in the elderly, have outlined the importance of achieving tight glycaemic control in order to prevent complications. Eighty years after its discovery, subcutaneous insulin remains a major treatment for diabetes. It is used as a first-line agent in type 1 diabetes, and in type 2 diabetes when oral antihyperglycaemic agents combined with diet and exercise fail to achieve an appropriate metabolic control. To avoid injections, other routes of insulin administration have been studied, including oral, dermal and rectal routes but they were not found to be appropriate for clinical use. Buccal or nasal insulin combined with absorption enhancers proved to have interesting properties. Inhaled insulin appears to be suitable for use in patients with diabetes because of its better bioavailability and a pharmacokinetic profile that mimics the time kinetics of insulin secretion after a meal. Clinical studies were conducted among small numbers of patients with type 1 or type 2 diabetes who had been treated with subcutaneous insulin. Inhaled insulin was given three times daily, just before meals, and was combined with a bedtime subcutaneous injection of long-acting insulin. In patients with type 1 or type 2 diabetes the metabolic control achieved with inhaled insulin was similar to that obtained with a subcutaneous insulin regimen. Tolerance of inhaled insulin was good and treatment satisfaction was better than that with the subcutaneous regimen. Insulin inhalation appears to be an interesting way of insulin delivery for elderly patients with diabetes. However, no studies have been conducted in elderly patients with diabetes to assess this route's acceptability, convenience and ease of use in this particular population. In addition, it is necessary to conduct pharmacokinetic studies in the elderly because lung aging might reduce the bioavailability of inhaled insulin.