• Brand name: Humalog®. Also available as a premix with NPL, called Humalog Mix25 (see below).
• Class: insulin analog.
• For: insulin-treated diabetes.
• Route of Administration: subcutaneous.
• Action: monomeric form of Regular insulin heximer, absorbed more rapidly.
• Manufacturer: Eli Lilly
• Status: US FDA application approved, June 1996. For sale under the brand name Humalog® as a prescription product in the U.S. as of August, 1996. Lispro also has been approved by the European Medicine Evaluation Agency, and is available in many countries (see below).
• Other drugs with approximately the same duration of action: Insulin glulisine (Apidra®), Insulin aspart (NovoRapid®, NovoLog®).

FDA approves Eli Lilly's Humalog for use in pediatric, geriatric diabetics

Humalog Mix25

Information received August 13, 1996 from Eli Lilly and Company:

"Humalog® — Initiation of Therapy

"Insulin lispro, like human insulin, must be adjusted to meet the specific needs of the patient. Dosages should be individualized based on physiologic response under close medical supervision. The total daily dose of rapid-acting insulin (insulin lispro or regular human insulin) and the total daily dose of basal insulin were similar during clinical trials with insulin lispro and regular human insulin.

"Converting from Regular Insulin

"Any change in insulin should be made cautiously and only under medical supervision. Insulin Lispro and human insulin are equivalent on a unit to unit basis. However, due to the more rapid onset of action of insulin lispro, the time of administration prior to meals should be decreased, with insulin lispro given within 15 minutes of a meal. Human regular insulin should be given 30 to 45 minutes prior to eating. Patients shoud be instructed on the improtance of eating after insulin dosing.

"Insulin lispro and regular human insulin are equipotent... The total daily dose of rapid-acting insulin (insulin lispro or regular human insulin) and the total daily dose of basal insulin were similar during clinical trials with insulin lispro and regular human insulin. However, individuals may need to adjust their insulin dosage after converting from regular human insulin to insulin lispro.

"Basal Insulin

"During multicenter, multinational controlled clinical trials involving over 300 Type I and Type II patients comparing inslin lispro to regular human insulin in combination with basal insulin (NPH or ultralente), the total daily dose of rapid-acting insulin and basal insulin were similar for both group. However two additional clinical trials involving 985 Type I and 713 Type II patients showed those receiving insulin lispro required slightly more total daily basal insulin than those reveiving Humulin® R. Although these results were statistically significant (p<0.002), the increase in basal insulin doses was only 0.5 to 1.5 units per day greater in the group receiving insulin lispro and was not considered to be clinically significant. Long-term effectiveness as measured by hemoglobin A1c was similar in both group with HbA1c values showing significant improvement from baseline.

"Because insulin lispro has a shorter duration of activity than regualr insulin, the dose of basal insulin (NPH or ultralente) may need to be adjusted accordingly."

E-mail June 25, 1996 from Eli Lilly and Company:

"Eli Lilly and Company received clearance from the U.S. Food and Drug Administration to market Humalog® (insulin lispro injection [rDNA origin]) on Friday, June 14, 1996.

"Humalog® is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog® has a more rapid onset and a shorter duration of action than human regular insulin and, therefore, should be given within 15 minutes of eating a meal. Humalog® should be used in regimens including a longer-acting insulin.

"Humalog® is expected to be available in pharmacies and hospitals by late August or early September 1996. The price has not yet been announced.

"This product will be available by prescription only. Any changes in insulin therapy should be made cautiously and only under medical supervision."

What letter will be on the bottle?

Insulin products have had a single large letter (N, L, U, R, etc) or number (70/30, 50/50) on the bottle which makes it easier to identify the product from a distance or in low-vision situations. What letter will be on lispro bottles? L is already in use for Lente. LP (for LisPro) or H (for Humalog) sound reasonable; however, it now turns out (August, 1996) that there will not be a letter on the bottle at all!

Humalog® (insulin lispro) Facts

• First new insulin in 14 years
• Discovered in 1989 and developed by Lilly scientists
• Two amino acids in the human insulin molecule -- proline and lysine -- were reversed to create Humalog®
• Amino acid switch causes Humalog® to work faster than other insulins
• First used as experimental therapy in human clinical trials in 1990
• To date, more than 2,900 people with diabetes in 19 countries around the world have used Humalog® in clinical trials
• Mimics the body's own rapid insulin secretion after eating a meal
• Should be injected up to 15 minutes before a meal
• Acts faster than regular human insulin to control blood-glucose levels after a meal
• Will be manufactured in Indianapolis, Indiana, and Fegersheim, France
• First cleared for marketing in Russia in April 1995
• Also approved for marketing in Australia, South Africa, Switzerland, the Czech Republic and 15 European Union member countries
• Commercially available in Russia, Switzerland, South Africa, the United Kingdom, Sweden and Germany
• Recommended for U.S. marketing clearance in February 1996 by advisory committee to FDA
• Sold in 10ml vials and 1.5 ml cartridges

Reprinted from Doctor's Guide to the Internet