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Pennington Biomedical Research Center Now Seeking Participants with Diabetes for Clinical Research Studies Using Investigational Inhaled InsulinArea Residents with Type 1 and Type 2 Diabetes Sought to Participate in Research for Condition that Affects Over 26 Million Americans
Released: Tuesday, April 17, 2012
BATON ROUGE, LA - Pennington Biomedical Research Center announced today that it will conduct two new clinical research studies evaluating an investigational, inhaled mealtime insulin (called AFREZZA® (insulin human [rDNA origin]) Inhalation Powder) in patients with type 1 and type 2 diabetes. 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 first research study in subjects with type 1 diabetes, called the Affinity 1 Trial, is to compare the investigational inhaled insulin administered at mealtime in combination with basal insulin to insulin aspart, a mealtime insulin therapy, in combination with basal insulin.
The goal of the second research study in subjects with type 2 diabetes, called the Affinity 2 Trial, is to determine if inhaled insulin 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. Both research studies are funded by MannKind Corporation.
"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 principal investigator William T. Cefalu, M.D., Associate Executive Director of Clinical Research and the Douglas L. Manship, Sr. Endowed Professor in Diabetes at Pennington Biomedical. "These research studies of an investigational inhaled insulin may provide an option for patients with diabetes."
Pennington Biomedical Research Center is seeking participants 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 (225) 763-3000 or visit www.PBRC.edu.
The Pennington Biomedical Research Center is at the forefront of medical discovery as it relates to understanding the triggers of obesity, diabetes, cardiovascular disease, cancer and dementia. It is a campus of Louisiana State University and conducts basic, clinical and population research. The research enterprise at Pennington Biomedical includes approximately 80 faculty and more than 25 post-doctoral fellows who comprise a network of 44 laboratories supported by lab technicians, nurses, dietitians, and support personnel, and 13 highly specialized core service facilities. Pennington Biomedical’s more than 500 employees perform research activities in state-of-the-art facilities on the 222-acre campus located in Baton Rouge, Louisiana.