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Item #13
Absorption
and Metabolic Effect of Inhaled Insulin
Intrapatient
variability after inhalation via the Aerodose Insulin Inhaler in
patients with type 2 diabetes
The
object of the study was to compare the intrapatient variability of the
pharmacokinetic and pharmacodynamic responses to inhaled regular
insulin (INH) delivered via the Aerodose Insulin Inhaler with
that of subcutaneously injected regular insulin (SC) in patients
with type 2 diabetes.
A
total of 15 patients with type 2 diabetes (nonsmokers, 10
men, aged 47–77 years) received two 240-unit doses of
INH, delivered via a clinical Aerodose Insulin Inhaler and
two 24-unit doses of SC under euglycemic clamp conditions
on four separate study days. Glucose infusion rates (GIRs)
and serum insulin concentrations were monitored over the
following 8 h. Comparisons of intrapatient coefficients of
variation (CV) were used to assess the reproducibility of INH
versus SC.
The
results showed that INH had a bioavailability (0–8 h postdosing)
of 16% and biopotency of 13% relative to SC. Comparison of the
CVs (%) for area under the curve for serum insulin and GIR
between INH and SC showed no significant differences
between the treatments during 0–3 h (19% for INH versus
23% for SC) or 0–8 h (22% for INH versus 16% for SC). INH
exhibited a shorter time to peak insulin concentration (Tmax
[mean ± SD] 76 ± 51 vs. 193 ± 66 min) and shorter time
to peak metabolic effect (TGIRmax 170 ± 53 vs.
244 ± 75 min) compared with SC (P < 0.001). No
adverse events were observed.
It
was concluded that comparable dosing reproducibility and shorter time
to peak action of INH compared with SC suggest that INH delivered
via the Aerodose Insulin Inhaler can provide reliable preprandial
dosing of insulin in patients with type 2 diabetes. Diabetes
Care 25:2276-2281, 2002
FACT:
In
1996, death certificate data listed diabetes as a potential
contributing cause of death for more than 193,410 persons. This
statistic may be underestimated since diabetes is believed to be
underreported on death certificates, both as a condition and as a
cause of death (Centers for Disease Control and Prevention, 1998).
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