Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study.
OBJECTIVE
Proof-of-concept study of evaluation of metabolic effect of novel oral spray insulin (Oralin) formulation at breakfast time in subjects with type 2 diabetes on multiple daily injections.


METHODS
This was an open-label, crossover, randomized study in (n = 23) subjects with type 2 diabetes on multiple daily injections. Subjects received each treatment, in random order, 3 to 7 days apart-a daily dose of SC injection (0.1 u/kg) on one occasion and Oralin spray (100 u) at time 0 min on another occasion. Subjects were given a standard breakfast containing 360 cal (Sustacal liquid meal) 10 min after the dose. Blood samples were taken at regular intervals to measure glucose, insulin, and C-peptide.


RESULTS
The 30- and 60-min postprandial glucose levels were significantly lowered with Oralin versus that with the injection treatment (146 +/- 5 mg/dL Oralin vs 184 +/- 7 mg/dL injection at 30 min and 192 +/- 6 mg/dL Oralin vs 236 +/- 9 mg/dL injection, p < 0.003 at 60 min). The rise in serum insulin levels was significantly higher (Cmax = 98 +/- 6 uU/mL for Oralin at 30 min vs 65 +/- 3 uU/ml injection, p < 0.001). The reduction in C-peptide was greater in Oralin during the first 60 min (1.38 +/- 0.21 ng/mL Oralin vs 1.75 +/- 0.38 ng/mL injection, p < 0.001).


CONCLUSIONS
This proof-of-concept study results demonstrated that Oralin could be used as meal insulin in place of mealtime-insulin injections in subjects with type 2 diabetes to regulate the postprandial glucose levels.
Guevara-Aguirre
Jaime
J
Institute of Endocrinology IEMIR, Quito, Ecuador.
Guevara
Marco
M
Saavedra
Jeannette
J
Mihic
Marko
M
Modi
Pankaj
P
D000284:Administration, Oral; D000336:Aerosols; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D016896:Treatment Outcome
D000336:Aerosols; D001786:Blood Glucose; D002096:C-Peptide; D007004:Hypoglycemic Agents; D007328:Insulin