On May 10, Generex Biotechnology Corp. of Toronto announced it has commenced long-term, phase II clinical trials of its oral insulin. The trials will be conducted in people with type 1 and type 2 diabetes.
The trials will test the safety and efficacy of the oral insulin formulation for a minimum of six months. Specifically, these trials will involve the use of the oral insulin formulation to:
- replace mealtime insulin injections in insulin-dependent people with type 1 and type 2 diabetes
- replace failing tablet therapy in people with type 2 diabetes
Administered as a Spray into the Mouth
Generex’s oral insulin is administered as a fine spray into the mouth via RapidMist-a small device that looks like an asthma inhaler.
According to Generex, there are currently 10 clinical sites in the United States, five sites in Canada and three sites in Europe participating in the long-term trials using the oral insulin formulation. Among these sites are The Diabetes and Glandular Disease Clinic of San Antonio, Texas and The National Research Institute of Los Angeles.
“We believe these long-term trials will demonstrate the positive benefits of oral insulin in helping type 1 and type 2 diabetics in achieving better control of this devastating disease,” said Dr. Pankaj Modi, Generex’s vice president of research. “Significantly, oral insulin will have an impact in the treatment of type 2 patients who are failing tablet therapy, since use of the oral insulin formulation will prevent the otherwise necessary insulin injection therapy.”