Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Family Medicine
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Humalog (insulin lispro)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Eli Lilly
Approval Status: Approved June 1996
Treatment Area: type 1 and type 2 diabetes
Humalog, an insulin analog of recombinant DNA origin, has been
approved for the treatment of type I and type II diabetes. Humalog
is the first of a new type of insulin that is designed to mimic the
body's own normal rapid insulin response.
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.
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
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.