The image is of Generex's exhibition booth at ADA 2011, courtesy of Generex's Todd Falls. Click the image to enlarge. The abstract being presented at ADA 2011 highlights final six month data from a Phase II study with IGT subjects, or prediabetics, which may present a paradigm change in how they are treated. The following is the abstract from the event:
Treatment of Impaired Glucose Tolerance with Buccal Spray Insulin: A 6 Months Randomised Controlled Trial
Author(s): ANDREA PALERMO, NICOLA NAPOLI, ERNESTO MADDALONI, ANGELO LAURIA, SILVIA MANFRINI, MARIA ALTOMARE, SERGIO LEOTTA, PAOLO POZZILLI
Abstract Body: In patients with impaired glucose tolerance (IGT), upon implementation of life style changes and metformin, a third returns to normal glucose tolerance, a third continues with IGT and the rest goes on to develop clinical type 2 diabetes. An increased risk for cardiovascular disease occurs in the latter two groups even though there is no progression to diabetes. A previous proof of concept study demonstrated that treatment with 12 puffs of buccal spray insulin was followed by a significant 29.6% decrease in mean plasma glucose at two-hours and a 26.8% decrease at three-hours.
We have designed a randomized controlled trial in patients with IGT comparing buccal spray insulin (Ora-lyn) (12 puffs per meal) plus physical exercise and diet (treatment group A, n=16, HbA1c at entry 6.06% + 0.5) vs. physical exercise and diet only (control group B, n=16, HbA1c at entry 5.9% + 0.3). HbA1c levels, metabolic parameters and insulin antibodies were measured at baseline and every 3 months up to 6 months. Primary endpoint is the reduction of HbA1c of 0.3% at 6 month treatment between the experimental and the control group. Secondary endpoints include the evaluation of antibodies against insulin (IA), changes in body weight and number of hypoglycaemic events.
Subjects treated with buccal spray insulin achieved a significant reduction of HbA1c compared to the control group (Δ HbA1c 0'- 6 month -0.34%+0,1 vs +0.07%+ 0,1 p =0,03). There was no significant difference in body weight and no hypoglycaemic or other adverse events were observed during the study period in both groups. No generation of IA was observed in subjects with IGT treated with buccal spray insulin.
These preliminary results indicate that buccal spray insulin is an effective treatment compared to diet + physical exercise in patients with IGT in reducing HbA1c without adverse effects. A larger trial is required to demonstrate the long term effects of this therapy. Here is the link.
According to data from the 2011 National Diabetes Fact Sheet, 79 million people in the U.S. have prediabetes (IGT). As obesity rates rise, so does the need to medically treat this group when the current recommendations of diet and exercise fall short. We have learned in recent weeks that the ongoing Phase III study in Type 1 patients has reached a protocol approved amount of subjects, and will be closed to new recruits. Final data may be available by the end of the year.
We now see positive Phase II results in IGT subjects, and plans to intitiate a Phase III study in Type 2 patients, anticipated to be completed by the end of 2013. A much broader label is being pursued for Oral-lyn, beyond Type 1's, whom make up only 10% of the US insulin market. With no adverse events reported in any studies, or cited as a concern in recent FDA guidance, Oral-lyn represents the next big thing that the current market does not understand.