Efficacy and tolerance of intranasal insulin administered during 4 months in severely hyperglycaemic Type 2 diabetic patients with oral drug failure:a cross-over study

Aims We have evaluated the local tolerance and the metabolic efficacy of a lyophilized nasal insulin preparation in 10 severely hyperglycaemic Type 2 diabetic patients. Methods The study included two 4-month randomized periods: (A) three prepra ndial doses of nasal insulin secondarily combined with one evening subcutan eous NPH if the desired glycaemic control was not achieved; (B) two NPH inj ections daily. We assessed: (i) diabetes control on monthly HbA(1c) levels and occurrence of hypoglycaemic events; (ii) local tolerance on clinical sy mptoms, rhinoscopy, nasal muco-ciliary clearance and nasal biopsies; (iii) insulin absorption at months 0 and 4. Results One patient was withdrawn because of cough and dizziness after each nasal application. HbA(1c) was not significantly different at month 4 (9.4 +/- 0.5% vs. 8.8 +/- 0.2%, A vs. B). Blood glucose control remained only f air in the majority of our patients. Nasal insulin was able to replace the daytime fraction of the subcutaneous insulin with a 18% efficacy. Side-effe cts included transient nasal hyperactivity (pruritis, sneezing and rhinorrh oea) and chronic persistence of nasal crusts. Plasma insulin profiles were not significantly different between months 0 and 4. Conclusions The utilization of nasal insulin (with or without NPH) was asso ciated with similar diabetes control compared with NPH twice daily. Nasal i nsulin alone was able to achieve an adequate glycaemic control in three of the 10 patients.