ADdition of Oral-LynTM at Meal-Times in Subjects with Type-2 Diabetes Maintained on Glargine + Metformin - A Comparison with Placebo
Itamar Raz, Angelina Dubinsky, Miriam Kidron, Julio Wainstein
Affiliation : Haddassah Hospital, Jerusalem, Israel
Background and Aims. The purpose of the study was to determine the metabolic effect of novel oral insulin
spray formulation at meal-time, on a long term basis (12 weeks), in subjects with Type-2 diabetes, maintained
on once a day s.c. Glargine insulin injection therapy at bed time and Metformin. The primary hypothesis is
that Oral-lyn™ can be used safely at meal-times and will improve 7 point glucose profiles, fructosamine and
the baseline HbA1c levels 12 weeks after treatment. The Oral-lyn™ system is based on a unique liquid aerosol
formulation, which allows a precise insulin dose delivery by mouth.
Materials and Methods. This was a randomised, double blind, long term (12 weeks) study in 26 Type-2
diabetic subjects (male or female) with poorly controlled blood glucose maintained on once a day s.c. 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™ device operation and dosing schedules, they were
divided into two groups. One group had 7 puffs of Oral-lyn™ TID, and the other group had 7 puffs of placebo
TID. Both groups took the puffs 10 min before meal time, in addition to their regular treatment. In cases where
self glucose values were above 12mmol/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.
Results. 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%+53.7 to 178.5mg%+39.1) in the Oral-lyn™
group versus 3.9% elevation (from 202.7mg%+60.1 to 210.1mg%+5.2) in the placebo group (p<0.05).
Furthermore, we found 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).
Conclusion. In Type-2 diabetic patients, maintained on Glargine and Metformin, Oral-lyn™ was especially
effective in controlling post-prandial glucose excursions.
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