Clinical Results

The approval of Humalog was based on data from worldwide clinical studies that included approximately 3,000 subjects who were evaluated over three years. Diabetics who participated in clinical trials injected Humalog within 15 minutes of eating a meal instead of injecting regular human insulin between 20 and 45 minutes before. Clinical trial evidence showed that Humalog acted faster than regular human insulin to control blood-glucose levels after a meal.

Mechanism of Action

Humalog was discovered and developed by scientists who found that the absorption of insulin injected under the skin could be accelerated by changing the order of two amino acids in the human insulin molecule. Humalog is designed to more closely mimic the body's own natural output in response to eating a meal.

Additional Information

More than 16 million people in the United States suffer from diabetes, which is the fourth-leading cause of death each year. In the United States alone, the disease costs society some $92 billion each year, according to the American Diabetes Association.

People with diabetes have to monitor blood-glucose levels and sometimes inject insulin several times a day to help their bodies process food. For people who are using regular human insulin, health care professionals recommend that injections be timed at least 30 to 45 minutes prior to a meal to allow the medication to begin working.

A 1995 survey of 453 insulin-using subjects with type 1 and type 2 diabetes showed that 43% injected insulin closer to their meals than recommended. Only 25% of the subjects surveyed took their insulin more than 30 minutes before they ate. Taking insulin too close to a meal can increase a subject's risk of hyperglycemia (high blood sugar) shortly after the meal and hypoglycemia (low blood sugar) before the next meal.