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Diabetes is a disease characterized by abnormally high levels of blood glucose and inadequate levels of insulin. Glucose is a simple sugar used by all the cells of the body to produce energy and support life.

Humans need a minimum level of glucose in their blood at all times to function and stay alive. Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body's management of glucose.

When a healthy individual begins a meal, the pancreas releases a natural spike of insulin, called the first-phase insulin release, which is critical to the body's overall control of glucose.

Many patients with diabetes lack the first-phase insulin release and must treat themselves with daily meal-time insulin injections to avoid the negative effects of hyperglycemia and hypoglycemia.

BIOD-Adjustable Basal

BIOD-Basal is a 24-hour basal insulin that is being developed in slow-, medium- and fast-acting forms to allow customized 24-hour dosing for each patient and reduce the risks of hypoglycemia and hyperglycemia.

A basal insulin which could have its duration lengthened or shortened would allow physicians to personalize insulin doses to the patient’s specific needs. If found to be effective, BIOD-Basal would be an improvement over current 24-hour insulins which may not work equally well for every patient, and would allow patients to determine the most effective basal insulin combination for managing their diabetes.

Biodel is pursuing development of BIOD-Basal as a modified form of recombinant human insulin and other insulin products under section 505(b)2 of the Federal Food, Drug and Cosmetic Act which governs the review of an NDA for a modified form of a previously approved product.