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Clinical Research Studies Using Investigational Inhaled Insulin Now Seeking Patients with Diabetes in St. Louis, MO

BY mattcmcspr | Posted: Monday, June 04, 2012 04:25 PM

Area Residents with Type 1 and Type 2 Diabetes Sought to Participate in Research into Condition that Affects Over 26 Million Americans

Saint Louis, 2012 – Two clinical research studies evaluating AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, an investigational, inhaled mealtime insulin, in patients with type 1 and type 2 diabetes, are now underway at sites throughout the United States, including Washington University School of Medicine. An estimated 26.8 million people in the United States have diabetes, a condition that affects 246 million people worldwide and is expected to affect 380 million by the year 2025.

The purpose of the research study in subjects with type 1 diabetes, called the Affinity 1 Trial, is to compare AFREZZA administered at mealtime in combination with basal insulin to insulin aspart, a mealtime insulin therapy, in combination with basal insulin.

The goal of the research study in subjects with type 2 diabetes, called the Affinity 2 Trial, is to determine that AFREZZA is superior to placebo in reducing HbA1c levels in patients with type 2 diabetes whose HbA1c levels are currently inadequately controlled with metformin or two or more oral diabetes therapies.

“Diabetes is a serious medical concern and a growing epidemic in the world, and despite the availability of numerous effective treatments, there remains a need for additional treatment options,” said Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine. “These research studies of an investigational inhaled insulin may provide an option for patients with diabetes.”

Washington University School of Medicine, one of the sites participating in the two trials, is seeking patients, 18 years of age or older, who:

· Have been diagnosed with type 1 or type 2 diabetes for more than one year

· Are nonsmokers or have ceased smoking for more than six months

· Have HbA1c levels between 7.5% and 10.0%

· If they are type 1, have been taking maintenance/mealtime insulin therapy for at least three months with a fasting plasma glucose (FPG) of less than 220 mg/dL, or

· If they are type 2, have taken only metformin or two or more oral diabetes medications for at least three months

Patients who are interested in enrolling or learning more about either of the two studies may call 877-232-9178 or visit www.YourDiabetesStudy.com.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its lead product candidate, AFREZZA®, is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

http://interact.stltoday.com/pr/lifestyle/PR06041204259279

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