A new fast-acting insulin was recently approved by the FDA: NovoLog (insulin aspart). Manufactured by Novo Nordisk A/S, a Denmark-based company, NovoLog received marketing approval from the FDA on June 7, 2000 for the treatment of type 1 and type 2 diabetes. The insulin has been marketed under the name NovoRapid outside the U.S., including several European countries.
NovoLog – the latest in a series of new manmade insulins – has a unique molecular structure that allows it to be absorbed more quickly and to work faster than regular human insulin. The ability of NovoLog to lower blood sugar levels quickly will allow people with diabetes to inject themselves with insulin immediately before eating – rather than 30 minutes prior to a meal, which is necessary with regular human insulin. While NovoLog works faster than regular insulin, it does not last as long (three to five hours for NovoLog versus five to eight hours for regular insulin). Therefore, it should be used together with an intermediate or long-acting insulin, particularly in people with type 1 diabetes.
The safety and effectiveness of NovoLog were established in two six-month trials in 1,885 patients with type1 diabetes and 176 patients with type 2 diabetes. NovoLog was compared to regular human insulin (Novolin). NovoLog was administered by subcutaneous (under the skin) injection immediately before eating while regular human insulin was administered 30 minutes before meals. Basal insulin was also administered in either single or divided doses. The ability of the insulins to control blood sugar was comparable for both NovoLog and regular human insulin.
The total number of daily doses of insulin was greater in the patients using NovoLog (one to three units/day in people with type 1 diabetes and 2 units/day in those with type 2 diabetes) compared to those taking regular human insulin. This was primarily due to differences in basal insulin requirements. In other clinical studies, it was shown that the incidence of low blood sugar (hypoglycemia) was lower among patients taking NovoLog than in those using regular human insulin.
Because of its fast onset of action, the injection of NovoLog should immediately be followed by a meal. Insulin therapy may be associated with hypoglycemia, worsening of diabetic retinopathy (a disorder of the retina of the eye), skin reactions (such as injection-site reaction, itching and rash), allergic reactions and retention of fluid. Hypoglycemia is the most common adverse effect of insulins including NovoLog. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.
Any change in insulin should be made cautiously and only under medical supervision.
If NovoLog is mixed with NPH human insulin, NovoLog should be drawn into the syringe first, and the injection should be made immediately after mixing.