This may have important implications for the use of insulin, a large molecule which is absorbed into the blood relatively slowly. Biodel’s technology facilitates more natural and rapid absorption of recombinant human insulin than current insulin products and appears to improve its therapeutic efficacy in patients with Type 1 and Type 2 diabetes.
Clinical studies indicate that Biodel’s lead ultra-rapid-acting insulin product candidate, BIOD-123, may be delivered into the bloodstream faster than regular human insulin and rapid-acting insulins.
None of the currently marketed meal-time insulin products adequately mimic the first-phase insulin release. The natural spike of the first-phase insulin release in a person without diabetes occurs within several minutes of glucose's entry into the bloodstream after a meal. By contrast, injected human insulin enters the bloodstream slowly, with peak insulin levels occurring within 120 to 180 minutes following the injection. One of the key improvements in insulin treatments was the introduction of rapid-acting insulin analogs, such as Humalog®, Novolog® and Apidra®. However, even with the rapid-acting insulin analogs, peak insulin levels typically occur within 50 to 70 minutes following the injection. The failure of currently marketed insulin products to adequately mimic the first-phase insulin release results in deficient insulin levels at the beginning of a meal and excessive insulin levels between meals. This time lag in insulin delivery can result in excessive glucose levels shortly after eating, leading to hyperglycemia and then, two to three hours later, inadequate glucose levels between meals, which may lead to hypoglycemia. These swings between excessive and inadequate levels of insulin are highly deleterious to the health of people with diabetes.