MannKind Corporation (Nasdaq: MNKD)
today announced positive preliminary results from Study 175, a Phase 3 clinical study of AFREZZA
(insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy administered using MannKind’s next-generation (Gen2) inhaler (also known as the Dreamboat™ inhaler), in patients with type 2 diabetes.
AFREZZA combined with oral therapy, compared to oral therapy alone, showed:
- Superior reductions in A1c levels;
- Significantly more patients reached A1c target levels;
- Reduced postprandial glucose excursions; and
- No significant difference in the incidence of severe hypoglycemia.
“We are pleased that Study 175 met its primary endpoint of demonstrating that AFREZZA, when added to a regimen of metformin with or without a second or third oral medication, produced superior A1c reductions compared to oral therapy alone,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “In this study, significantly greater numbers of patients in the AFREZZA group reached the American Diabetes Association goal of A1c levels less than or equal to 7.0% and the American Association of Clinical Endocrinologists goal of less than or equal to 6.5%. As well, the AFREZZA group exhibited noticeably reduced postprandial glucose excursions. As would be expected in a study that added insulin to an oral treatment regimen, hypoglycemic events were more frequent in the AFREZZA group, but no AFREZZA patient discontinued because of hypoglycemic adverse events. Based on the results of this study, we believe that AFREZZA can be used to improve glycemic control in insulin-naive type 2 diabetes patients that are not adequately controlled on conventional oral medications – a potentially large and underserved patient population.”
Study 175 was a double-blind, placebo-controlled study involving 353 patients with type 2 diabetes whose disease was inadequately controlled on metformin with or without a second or third oral medication. Patients were studied at sites in the United States, Russia, Ukraine and Brazil. After a six-week run-in period during which all patients received dietary counseling and initiated blood glucose monitoring while continuing their oral medications, patients entered a 24-week treatment period in which they were randomized to one of two groups where, in addition to their oral medication, they received either:
- AFREZZA Inhalation Powder, administered using the Gen2 inhaler (177 patients); or
- Technosphere Inhalation Powder (placebo), administered using the Gen2 inhaler (176 patients).
The treatment period consisted of 12 weeks of prandial insulin titration followed by 12 weeks of relatively stable dosing. Subjects could not adjust or alter the doses of their oral medications during the study without discussion between the principal investigator and the medical monitor. There was also a safety follow-up visit four weeks after completion of the treatment period, during which all subjects returned to oral therapy only.