title: Intranasal insulin: the effects of three dose regimens on postprandial glycaemic profiles in type II diabetic subjects.
abstract: In both fasting normal and diabetic subjects, nasally administered insulin achieves significant falls in plasma glucose concentrations. Repeated administration before and during a meal has been necessary to lower postprandial glycaemic excursion in subjects with NIDDM. We have studied the use of Novolin Nasal which employs a non-irritant, lecithin-based enhancer as a vehicle for human insulin, on postprandial glucose profiles in NIDDM subjects to determine efficacy, optimal dose frequency, and tolerability. Seventeen NIDDM subjects (15 men, 2 women) participated in a randomized, partially blinded, placebo-controlled, crossover trial of three active treatment regimens (nasal insulin, 120 U at 0 min, 60 U at 0 and +20 min or 120 U at +20 min) in relation to a standardized mixed meal given at 0 min. All active treatments significantly reduced postprandial glucose concentrations compared to placebo. Intranasal insulin given at 0 min at a dose of 60 U or 120 U resulted in a 50% reduction in postprandial incremental glucose compared to placebo over the first 2 h, whereas treatment with 60 U both at 0 and 20 min lead to a 70% reduction over the 240 min postprandial period. Post-prandial intravenous insulin was the least effective. There were no episodes of symptomatic hypoglycaemia. Local tolerability was excellent with only four reports of transient nasal irritation out of a total of 68 doses. The delivery device was accurate with intra-device CV of delivered dose of 4.8%.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Diabetes Research Unit, University Hospital of Wales, Heath Park, Cardiff, UK.
authors.forename: P A
authors.initials: PA
authors.lastname: Coates
authors.forename: I S
authors.initials: IS
authors.lastname: Ismail
authors.forename: S D
authors.initials: SD
authors.lastname: Luzio
authors.forename: I
authors.initials: I
authors.lastname: Griffiths
authors.forename: R L
authors.initials: RL
authors.lastname: Ollerton
authors.forename: A
authors.initials: A
authors.lastname: Vølund
authors.forename: D R
authors.initials: DR
authors.lastname: Owens
mesh_terms: D000281:Administration, Intranasal; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004435:Eating; D005215:Fasting; D005260:Female; D006801:Humans; D007328:Insulin / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012016:Reference Values; D016037:Single-Blind Method; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D007328:Insulin; D010919:Placebos