AFREZZA provides long-term glucose control in Type 2 diabetics: Study

MannKind CorporationJun 29 2010

AFREZZA^TM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, as part of a diabetes treatment regimen, provides long-term glucose control comparable to usual insulin therapy but with a significantly reduced incidence of hypoglycemia and less weight gain in patients with Type 2 diabetes, according to a two-year study presented today at the American Diabetes Association's 70^th Scientific Sessions.

“While insulin therapy is accepted as an effective means to control glucose levels, currently available mealtime insulin products have several limitations, including the risk of severe hypoglycemia”

"While insulin therapy is accepted as an effective means to control glucose levels, currently available mealtime insulin products have several limitations, including the risk of severe hypoglycemia," said Philip Raskin, M.D., Clifton and Betsy Robinson Chair in Biomedical Research, Southwestern Medical School, University of Texas. "Our results add to the growing body of evidence that AFREZZA is effective in controlling blood sugar levels in patients with Type 2 diabetes, and provides the added benefits of a significant reduction in severely low blood sugar levels and less weight gain as compared to standard of care insulin therapy."

Diabetes, which affects 23.6 million people in the U.S., is characterized by the body's inability to properly regulate levels of blood glucose, or blood sugar. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces. 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 light, 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.