Pa. Coates et al., INTRANASAL INSULIN - THE EFFECTS OF 3 DOSE REGIMENS ON POSTPRANDIAL GLYCEMIC PROFILES IN TYPE-II DIABETIC SUBJECTS, Diabetic medicine, 12(3), 1995, pp. 235-239
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Categorie Soggetti
Endocrynology & Metabolism","Medicine, General & Internal
In both fasting normal and diabetic subjects, nasally administered ins
ulin achieves significant falls in plasma glucose concentrations. Repe
ated administration before and during a meal has been necessary to low
er postprandial glycaemic excursion in subjects with NIDDM. We have st
udied the use of Novolin(R) Nasal which employs a non-irritant, lecith
in-based enhancer as a vehicle for human insulin, on postprandial gluc
ose profiles in NIDDM subjects to determine efficacy, optimal dose fre
quency, and tolerability. Seventeen NIDDM subjects (15 men, 2 women) p
articipated in a randomized, partially blinded, placebo-controlled, cr
ossover 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 signifi
cantly reduced postprandial glucose concentrations compared to placebo
. Intranasal insulin given at 0 min at a dose of 60 U or 120 U resulte
d 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 excel
lent with only four reports of transient nasal irritation out of a tot
al of 68 doses. The delivery device was accurate with intra-device CV
of delivered dose of 4.8 %. We conclude that nasal insulin is effectiv
e in reducing postprandial glycaemia in subjects with NIDDM and is wel
l tolerated. Repeated dosing achieved the greatest reduction in postpr
andial glycaemic responses to a mixed meal.