ormation Service. Duplication by any means is prohibited.
June 2007. Issue No. 146.
Windows on Medical Technology
Policy Statement
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June 2007. Issue No. 146.
Windows on Medical Technology
Checkpoints
Inhaled Insulin for the Treatment of Type 2 Diabetes Technology Description
Insulin for preprandial glucose control can be
administered through several routes, including,
but not limited to, injection and inhalation.
The inhaled insulin product on the market in the
United States and Europe is the Exubera® system.
The system consists of a 10-inch long
administration device that is used within
10 minutes before a meal, and the patient can
inhale specific insulin doses (e.g., 3 units, 6 units,
8 units, 11 units, or higher). Care Setting
Inhaled insulin can be used on an inpatient or
outpatient basis. Because inhaled insulin is used
just before meals, treatment with inhaled insulin
can occur in the home, workplace, or any setting
in which the patient requires insulin. Target Population
Patients with type 2 diabetes who use insulin
could potentially use inhaled insulin as an
alternate route of administration from injected
insulin. Patients with type 2 diabetes who do not
use insulin could potentially benefit from insulin
treatment in an attempt to improve glucose
control. Costs
ECRI Institute estimates that the annual wholesale
acquisition cost of Exubera for a typical patient
with type 2 diabetes is $1,578.00. Manufacturers
Pfizer Incorporated (Groton, CT, USA) and
Nektar Therapeutics (San Carlos, CA, USA)
developed the only inhaled insulin drug and
inhalation device currently on the market.
Eight other manufacturers have inhaled insulin
products currently in development. Regulatory Status
In January 2006, Exubera was approved for
marketing under the New Drug Application
process of the U.S. Food and Drug Administration
for the treatment of adult patients with type 1 and
type 2 diabetes. The approved indication is
for the treatment of

adult patients with diabetes
mellitus for the control of hyperglycemia.

Exubera
has an onset of action similar to rapid-acting
insulin analogs and has a duration of glucose-
lowering activity comparable to subcutaneously
administered, regular human insulin. In patients
with type 1 diabetes, Exubera should be used in
regimens that include a longer-acting insulin.
In patients with type 2 diabetes, Exubera can be
used as monotherapy or in combination with oral
agents or longer-acting insulins.
FDA classifies inhaled insulin delivery systems as
combination products (i.e., drug device), and has
adopted Good Manufacturing Practice guidelines
that require sterile production of inhalation
products and their devices.
In January 2006, the European Commission
approved Exubera for treatment of adults with
type 1 and type 2 diabetes. Clinical Guidelines and Standards
We identified no clinical practice guidelines or
standard pertaining to inhaled insulin products. Third-party Payer Status
We identified no policies pertaining to the
coverage or noncoverage of inhaled insulin. Phase of Diffusion
The technology is in an early phase of diffusion
and is diffusing more slowly than expected. Sales
of the drug/device have not met initial company
projections. Synthesis of Results
Searches identified eight randomized controlled
trials of inhaled insulin for type 2 diabetes. These
trials enrolled a total of 1,881 patients. We used
these trials to address seven key questions, which
are listed below with corresponding evidence-
based conclusions.
1.

For people with type 2 diabetes taking insulin,
does inhaled insulin provide similar glucose
control to short-acting injected insulin?
After 12 weeks of treatment, inhaled insulin
and injected insulin provide similar levels of

HbA
1c
. Strength of evidence: Moderate.
The estimated difference in 12-week HbA
1c

between inhaled and injected insulin is © ECRI Institute Health Technology Assessment Information Service. Duplication by any means is prohibited.
June 2007. Issue No. 146.
0.10% (95% confidence interval -0.09% to
0.28%). Stability of the 0.10 estimate: Low.
The evidence was insufficient to determine
whether there are differences in glucose
control at longer time frames.
2.

For people with type 2 diabetes taking insulin,
does inhaled insulin result in more short-term,
adverse events than short-acting injected
insulin?
The evidence was insufficient to determine
whether there are any differences in
short-term adverse events, including
hypoglycemia, weight gain, cough, and
lung function.
3.

Do people with type 2 diabetes taking insulin
experience greater treatment satisfaction and
quality of life (QoL) with inhaled insulin than
with short-acting injected insulin?
The evidence was insufficient to determine
whether patients taking inhaled insulin are
more satisfied or have improved QoL with
inhaled insulin.
4.

For people with type 2 diabetes taking insulin,
does inhaled insulin lead to fewer secondary
complications of diabetes and longer survival
than short-acting injected insulin?
No stud