Officials at MannKind reported results from the its Phase III study of inhaled insulin in patients with type 2 diabetes. This study was designed to evaluate whether the MannKind Technosphere® insulin system showed similar safety and efficacy compared to patients treated with insulin aspart (NovoLog®), an injected rapid-acting insulin analog (RAA).
“This study demonstrated that patients with type 2 diabetes using Technosphere Insulin achieved comparable improvements in glycemic control (HbA1c) to patients treated with an injected RAA,” points out Peter Richardson, CSO of MannKind. “In addition, we observed no adverse effect on pulmonary function in either treatment group. However, unlike the injected RAA group, Technosphere Insulin patients lost weight during the treatment period.”
The study included 308 patients with type 2 diabetes who where randomized to the mealtime use of either Technosphere Insulin (n=150) or injected RAA (n=158), plus insulin glargine as basal insulin. After a transfer period, patients were followed for 24 weeks, during which time individual adjustments of therapy were made.
Glycemic control in both treatment groups was assessed by periodic determinations of HbA1c levels, which measure the average blood glucose levels during the preceding three to four months. Pulmonary function was assessed by serial measurements of forced expiratory volume and forced vital capacity.
After the treatment period, patients reverted to conventional therapy and pulmonary function was followed for an additional 24 weeks.
Both patient groups achieved statistically significant improvements in HbA1c levels (1.05% in the Technosphere Insulin patient group and 1.30% in the injected RAA patient group). Pulmonary function did not differ between the two patient groups after six months of treatment and after the six-month withdrawal period. Significantly fewer patients experienced hypoglycemia in the Technosphere Insulin patient group than in the comparable injected RAA patient group.
After six months of treatment, the Technosphere Insulin patient group experienced a weight loss of 0.76 kg, compared with the injected RAA patient group, which saw an increase in weight of 0.23 kg (p=0.0007).
As in previous studies, mild cough was observed in a minority of patients treated with Technosphere Insulin.