Diabetes, affects 26.8 million people in the U.S. It is characterized by the body’s inability to properly regulate blood sugar levels. 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.
Current mealtime insulin therapy has a number of limitations, including the risk of severe hypoglycemia (low blood sugar), weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and, of course, the need for injections.
So Word on Health was excited to hear that needles may soon become a thing of the past. According to the manufacturer, investigational inhaled insulin works at least as well in patients with Type 1 diabetes as standard injection therapy.
MannKind Corporation announced yesterday that a new Phase III clinical trial showed that the ultra fast-acting inhaled insulin AFREZZA (insulin human [rDNA origin]) combined with basal insulin worked at least as well as injectable Humalog (insulin lispro [rDNA origin]). Additionally, patients receiving the inhaled insulin showed lower rates of hypoglycemia, lower fasting and post-prandial blood glucose levels than those receiving subcutaneous injections
“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., Professor, Departments of Pediatrics and Medicine, University of Colorado School of Medicine; Head, Young Adult Diabetes Clinic, Barbara Davis Center for Childhood Diabetes, and lead study investigator. “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.”
AFREZZATM is a drug-device combination product, consisting of Inhalation Powder and a small, easy- to-use 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.
MannKind is currently preparing its FDA resubmission of the AFREZZA new drug application and is hoping to gain approval for the treatment of adults with Type 1 or Type 2 diabetes.