AFREZZA(TM) Demonstrates Non-Inferiority Compared to Standard Therapy

MannKind Corporation announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA(TM) (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes.  

In addition, patients treated with AFREZZA had statistically significant lower rates of hypoglycemia, post-prandial glucose (PPG) levels when measured at 30, 60, 90 and 120 minutes, and fasting blood glucose (FBG) levels when compared to subcutaneously injected insulin lispro.  

"Effectively controlling blood sugar levels and managing hypoglycemic events go hand in hand as key to successfully treating patients with Type 1 diabetes," said Satish K. Garg, M.D., lead study investigator, Professor, Departments of Pediatrics and Medicine, University of Colorado School of Medicine. "Our findings demonstrate that AFREZZA may offer a significant advance from current mealtime insulin delivery methods, as it is comparable to the standard of care in glycemic control and provides the additional benefit of lower hypoglycemia rates."  

Historically, mealtime insulin therapy regimens have had a number of limitations, including the risk of severe hypoglycemia, the likelihood of weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and the need for injections. Additionally, these therapies have not mimicked the natural time-action profile of insulin normally seen in healthy individuals and presented challenges in maintaining compliance.  

AFREZZA(TM) is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the small, discreet and easy- to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals.  

To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both Type 1 and Type 2 diabetes.

In the intent-to-treat population, AFREZZA lowered HbA1c by -0.10% (mean change from baseline HbA1c) as compared to -0.03% in the lispro group. In addition, a significantly higher percentage of patients in the AFREZZA group (9.6%) reached an HbA1c goal of less than 6.5% compared to the lispro group (3.5%, p = 0.0277).

Even with matching levels of glargine, patients treated with AFREZZA experienced significantly greater decreases in FBG levels (mean change from baseline 41.53 mg/dl in the AFREZZA group versus 9.16 mg/dl in the lispro group, p = 0.0107). Patients treated with AFREZZA also experienced significantly lower PPG levels at 30, 60, 90 and 120 minutes (mean PPG levels at 30 minutes AFREZZA 130 mg/dl versus lispro 195.09 mg/dl; 60 minutes: AFREZZA 136 mg/dl versus lispro 214.49 mg/dl; 90 minutes: AFREZZA 163.94 mg/dl versus lispro 228.45 mg/dl; 120 minutes: AFREZZA 199.53 mg/dl versus lispro 241.39 mg/dl). In addition, patients treated with AFREZZA had significantly lower rates of total and mild/moderate hypoglycemia (6.2 versus 8.2 events per subject month [p=0.0345] and 6.0 versus 8.0 events per subject month [p=0.0269], respectively).