title: 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.
abstract: OBJECTIVE
  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 preprandial doses of nasal insulin secondarily combined with one evening subcutaneous NPH if the desired glycaemic control was not achieved; (B) two NPH injections daily. We assessed: (i) diabetes control on monthly HbA1c levels and occurrence of hypoglycaemic events; (ii) local tolerance on clinical symptoms, 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  One patient was withdrawn because of cough and dizziness after each nasal application. HbA1c was not significantly different at month 4 (9.4 +/- 0.5% vs. 8.8 +/- 0.2%, A vs. B). Blood glucose control remained only fair in the majority of our patients. Nasal insulin was able to replace the daytime fraction of the subcutaneous insulin with a 18% efficacy. Side-effects included transient nasal hyperactivity (pruritus, sneezing and rhinorrhoea) 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 associated with similar diabetes control compared with NPH twice daily. Nasal insulin alone was able to achieve an adequate glycaemic control in three of the 10 patients.
authors.affiliation: Diabetes Department, INSERM U341 and Pharmacy Department, Hotel-Dieu Hospital, Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Lalej-Bennis
authors.forename: J
authors.initials: J
authors.lastname: Boillot
authors.forename: C
authors.initials: C
authors.lastname: Bardin
authors.forename: P
authors.initials: P
authors.lastname: Zirinis
authors.forename: A
authors.initials: A
authors.lastname: Coste
authors.forename: E
authors.initials: E
authors.lastname: Escudier
authors.forename: F
authors.initials: F
authors.lastname: Chast
authors.forename: R
authors.initials: R
authors.lastname: Peynegre
authors.forename: J L
authors.initials: JL
authors.lastname: Selam
authors.forename: G
authors.initials: G
authors.lastname: Slama
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000097:blood*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D007336:Insulin, Isophane / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D008875:Middle Aged; D018579:Patient Selection; D017211:Treatment Failure
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D007336:Insulin, Isophane