Study Compares NovoLog Mix 70/30 to Biphasic Human Insulin 30

According to a two-year head-to-head study published in the European Journal of Internal Medicine, patients with Type 2 diabetes showed reduced incidences of major hypoglycemia when using NovoLog Mix 70/30 versus biphasic human insulin 30 (Novolin 70/30) (0 percent versus 10 percent) with comparable efficacy.

Symptoms associated with hypoglycemia, a condition that develops when blood glucose levels are critically low due to inappropriately matched levels of injected insulin, include disorientation, delirium, loss of consciousness, and in severe cases, coma and death. The two-year study, performed at 30 centers in Germany, was comprised of a three-month initial period followed by a 21-month extension period.

During the study, 190 Type 2 patients were randomized to receive NovoLog Mix 70/30 (70 percent insulin aspart protamine suspension and 30 percent insulin aspart injection, [rDNA origin]) or Novolin 70/30 (70 percent NPH, human insulin isophane suspension and 30 percent regular, human insulin injection [rDNA origin]) twice daily with their morning and evening meals, for a period of three months. A total of 125 (72 percent) Type 2 patients entered the 21-month extension. Patients entering the initial treatment period had Type 2 diabetes for more than 24 months, were aged 18 years or older, and had an A1C level equal to or below 11 percent.

Outcome measures for the initial study included postprandial and daily blood glucose control and hypoglycemia. Patients attended screening visits at regular intervals, and were assessed for long-term safety in terms of hypoglycemia and, secondarily, by adverse events.