The MannKind pulmonary insulin system rapidly delivers regular human insulin to the bloodstream in a manner that approximates the first phase insulin release spike by the pancreas that occurs almost immediately after the start of a meal in normal, healthy individuals but is lost in patients who develop diabetes.
This spike plays an important role in glucose control by signaling the liver to stop releasing glucose into the bloodstream while glucose is being ingested from a meal.
The double-blind, placebo-controlled study was conducted at 21 sites in the US. Patients who participated in the study were experiencing inadequate control of diabetes determined on the basis of HbA1c results (a measure of glucose control over the preceding three to four months) obtained at the time of screening.
In the study, patients with moderately severe elevations of HbA1c levels at baseline who were treated with Technosphere Insulin experienced a mean reduction of 1.37 percentage points by the end of 12 weeks of treatment. The difference in reduction of HbA1c levels between the Technosphere Insulin and the placebo treatment groups was highly statistically significant in favor of Technosphere Insulin.
Patients with mild to moderate elevations of HbA1c levels at baseline treated with Technosphere Insulin experienced a mean reduction of 0.43 percentage points by the end of 12 weeks of treatment. Here, the difference in reduction of HbA1c levels between the Technosphere Insulin and the placebo treatment groups was also statistically significant in favor of Technosphere Insulin.
Overall, approximately four times as many patients in the Technosphere Insulin-treated group achieved a final HbA1c level of 6.5% or less as compared to the placebo-treated group.
There were no serious adverse events that were related to the use of the study drug and no episodes of severe hypoglycemia occurred in any of the patients treated with Technosphere Insulin. Importantly, there was also no evidence of treatment-induced insulin antibodies occurring in patients treated with Technosphere Insulin.
Dr Wendell Cheatham, corporate vice president and chief medical officer of MannKind, commented, “This study indicates that Technosphere Insulin can effectively lower blood glucose levels in patients with type 2 diabetes who previously were experiencing inadequate control of their disease.”
MannKind is currently preparing to submit the results from this study to the FDA, and has begun its first phase III clinical trial in Europe.