Oral Insulin Oral-lyn ™ Effective In Controlling Post-prandial Glucose Excursion

The interim results, after 8 weeks of treatment, showed no change in fasting glucose while in post-prandial glucose there was a 15.4% reduction.

Generex Biotechnology Corporation, a leader in the area of buccal drug delivery, announced additional Oral-lyn(TM) clinical trial results. Professor Itamar Raz of Hadassah Hospital, Jerusalem, Israel and one of the principal investigators in the Company’s on-going clinical trials of Oral-lyn(TM), its proprietary oral insulin spray product, made a poster presentation titled “Addition of Oral-lyn(TM) at Mealtimes in Subjects with Type 2 Diabetes Maintained on Glargine + Metformin – A Comparison with Placebo.”

The purpose of the study was to determine the metabolic effect of Oral-lyn(TM) at mealtime on a long term basis (12 weeks) in subjects with Type-2 diabetes maintained on once-a-day subcutaneous glargine insulin injection therapy at bedtime and metformin. The primary hypothesis was that Oral-lyn(TM) can be used safely at mealtimes and will improve 7 point glucose profiles, fructosamine and the baseline HbA1c levels 12 weeks after treatment.

The Oral-lyn(TM) system is based on a unique liquid aerosol formulation, which allows a precise insulin dose delivery by mouth.

This was a randomized, double-blind, long-term (12 weeks) study in 26 subjects with Type-2 diabetes (male or female) with poorly controlled blood glucose maintained on once-a-day subcutaneous glargine + metformin. After the initial screening visit, subjects maintained their regular treatment for two weeks as a run-in period. Following the training of the Oral-lyn(TM) device operation and dosing schedules, they were divided into two groups. One group had 7 puffs of Oral-lyn(TM) TID and the other group had 7 puffs of placebo TID. Both groups took the puffs 10 minutes before mealtime in addition to their regular treatment. In cases where self glucose values were above 216 mg/dl (2mmol/L) before any meal or before bedtime, an additional 7 puffs were added. Each subject had routine blood chemistry and HbA1c as well as fructosamine levels at the beginning of the study and at the end of every month during the study period. Beginning with the initial screening visit, each subject had to monitor his/her blood glucose at least three times a day and once a week for a 7-point profile.

The interim results, after 8 weeks of treatment, showed no change in fasting glucose while in post-prandial glucose there was a 15.4% reduction (from 211.2mg% plus or minus 53.7 to 178.5mg% plus or minus 39.1) in the Oral-lyn ™ group versus 3.9% elevation (from 202.7mg% plus or minus 60.1 to 210.1mg% plus or minus 5.2) in the placebo group (p<0.05). Furthermore, there was a reduction of fructosamine in the Oral-lyn ™ group of 6.4% versus 3.6% in the placebo (p-NS) and in HbA1c - 6.6% reduction versus 3.4% in the placebo (p-NS).

The study concluded that, in patients with Type-2 diabetes maintained on glargine and metformin, Oral-lyn ™ was especially effective in controlling post-prandial glucose excursions.

Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist(TM) device. The Company’s flagship product, oral insulin (Oral-lyn ™, which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at https://www.generex.com.

The results were presented at the 41st Annual Meeting of the European Association for the Study of Diabetes (EASD) held in Athens, Greece last week.

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FACT:
Patient Education Prevents Diabetic Amputations: A study indicates that educating patients with type 2 diabetes on proper foot care can help prevent surgery for diabetic foot disease. In an evaluation of 4,872 high-risk diabetic patients, participants at high risk for foot complications were taught about diabetic foot disease, its complications, and prevention, and told to report back if new lesions appeared. The group that was most affected by the education—among 1,259 patients who presented for follow-up, 58% (718) adhered to what they were taught and 43% (541) did not. Ulcers were healed at follow-up in 82% (585) of patients with prior foot ulceration or peripheral vascular disease who followed clinical educational advice compared with only 50% (269) of patients who did not. Significantly more subjects who did not follow instructions developed new problems (26% vs 5% of patients who adhered to advice) and required surgery (14% vs 3%). May 2005 issue of Diabetes Care