At the 3rd month evaluation of this six-month trial, it was demonstrated that a trend similar towards normalization exists when replacing the lunch-time dose of regular insulin with the Generex Oral-lyn™ spray. In fact, not only Daily Glucose Profiles and Fructosamine demonstrated improved values but, of special importance, Glycosylated Hemoglobin (HbA1c), the criterion standard to evaluate metabolic control in Diabetes, showed a significant improvement when compared to standard therapy. The investigators concluded, in their three-month interim analysis, that successful and efficient replacement of injected regular insulin at lunchtime was achieved with Generex Oral-lyn™ altogether with 100% compliance.

These encouraging results prompted the investigators and the partners Generex-Pharmabrand to design studies using larger number of type-1 DM subjects and replacing the three mealtime doses of regular insulin with the Generex-Oral-lyn™ spray on subjects maintained in once daily glargine insulin therapy.