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. Research design and methods This was an open‐label, crossover, randomized study in (n = 23) subjects wi...

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Bibliographic Details
Published in:Diabetes/metabolism research and reviews 2004-11, Vol.20 (6), p.472-478
Main Authors: Guevara-Aguirre, Jaime, Guevara, Marco, Saavedra, Jeannette, Mihic, Marko, Modi, Pankaj
Format: Article
Language:English
Subjects:
Administration, Oral
Aerosols
Biological and medical sciences
Blood Glucose - metabolism
buccal spray insulin
C-Peptide - blood
Cross-Over Studies
diabetes management system
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Diabetes. Impaired glucose tolerance
Dose-Response Relationship, Drug
Drug Administration Schedule
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Female
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Injections, Subcutaneous
Insulin - administration & dosage
Insulin - blood
Insulin - therapeutic use
Male
Medical sciences
Middle Aged
oral spray insulin
Oralin
postprandial glucose
Postprandial Period
RapidMist
Treatment Outcome
type 2 diabetes
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Summary: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. Research design and 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. Copyright © 2004 John Wiley & Sons, Ltd.
ISSN:1520-7552
1520-7560
DOI:10.1002/dmrr.477