New form of inhaled insulin controls postmeal glycemia with minimal weight gain

June 7, 2009

An investigational ultra rapid-acting inhalable insulin (Technosphere™ Insulin) at mealtime in combination with basal insulin in patients with type 2 diabetes has glycemic efficacy over 52 weeks that is comparable to twice-daily premixed insulin analog 70/30 but with less risk of inducing weight gain and hypoglycemia, according to phase 3 data.

An investigational ultra rapid-acting inhalable insulin (Technosphere™ Insulin) at mealtime in combination with basal insulin in patients with type 2 diabetes has glycemic efficacy over 52 weeks that is comparable to twice-daily premixed insulin analog 70/30 but with less risk of inducing weight gain and hypoglycemia, according to phase 3 data presented by Julio Rosenstock, MD, clinical professor of medicine, Dallas Diabetes and Endocrine Center at Medical City, Dallas.

Technosphere Insulin is made of recombinant human insulin adsorbed onto Technosphere particles.

The inhaled insulin is dissolved immediately on contact with the lung surface, and the insulin is rapidly absorbed into systemic circulation. The time to maximum observed concentration is about 14 minutes. Most of the glucose-lowering effect is realized in the first 3 hours.

A new drug application for the insulin inhalation powder has been filed with the Food and Drug Administration for use in adult patients with type 1 and type 2 diabetes for the treatment of hyperglycemia.

Three-times daily prandial inhaled insulin plus insulin glargine as a basal/bolus regimen was compared with premixed biaspart (BPA) 70/30 twice daily in 654 patients with type 2 diabetes that was inadequately controlled (hemoglobin A1c [HbA1c] >7.0% and ≤11.0%) on previous insulin with or without oral agents. The patients could continue using the oral antidiabetic agents they were using at time of entry into the trial.

The primary endpoint was the mean change in HbA1c from baseline to week 52. In an intent-to-treat analysis, the mean change in HbA1c from baseline was –0.66% in the patients assigned to inhaled insulin compared to –0.72% in the BPA 70/30 arm, which met the criterion for noninferiority, reports Dr. Rosenstock.

The proportion of patients who achieved a final HbA1c of less than 7.0% was comparable between the two arms (22% for inhaled insulin vs 27% for BPA 70/30).

The 1-hour change in postprandial glucose levels after a meal challenge was significantly lower in the patients randomized to insulin inhalation powder compared to BPA 70/30 (37 mg/dL vs 54 mg/dL; p<0.0001).

Fasting plasma glucose levels at week 52 were significantly lower in the inhaled insulin group (139.8 mg/dL vs 156.0 mg/dL; p<0.0001).

Mean weight was significantly less in the group assigned to inhaled insulin (0.9 kg vs 2.5 kg; p=0.0002).

The incidence of both mild to moderate and severe hypoglycemia was significantly less in the patients in the inhaled insulin group. Mild to moderate hypoglycemia occurred in 48% of patients randomized to inhaled insulin versus 69% randomized to BPA 70/30 (p<0.001), and severe hypoglycemia occurred in 4% versus 10% (p=0.0066), respectively.

There were no differences in pulmonary function at week 52 between the two treatment groups.

In a separate 52-week study presented here, Technosphere Insulin was comparable to insulin aspart as rapid-acting insulins in reducing levels of HbA1c in patients with type 1 diabetes, with a significant advantage to Technosphere Insulin on weight change and mild to moderate and total hypoglycemia.