AACE:
Inhaled
Insulin Shows Better Results Subcutaneous Formulation
Inhaled
insulin reduced fasting and postprandial levels more effectively
than injectable insulin
The
investigational inhaled insulin agent Exubera® is well-tolerated
by patients with Type 1 diabetes and reduces fasting plasma
glucose and two-hour post-prandial glucose levels significantly
more effectively than does conventional subcutaneous insulin
treatment. That’s
what researchers reported from their multicenter study at the AACE
meeting in Chicago last week.
"This treatment
by inhalation -- pre-meal and in association with one injection of
long-acting insulin -- provides comparable control with less
incidence of blood sugar reactions, which is a major concern in
diabetes treatment," said Exubera phase III study group
researcher Teresa Quattrin, MD, associate professor of medicine at
the State University of New York Medical School in Buffalo.
"It was safe, well-tolerated and really made life better for
the patients, according to the 'treatment satisfaction'
questionnaires."
The patients were watched very closely to make sure they followed
the protocols and did not change their diet. "This form of
delivering insulin is novel, noninvasive and provides comparable
diabetes control to the conventional regimen, which requires two
to three injections daily," Dr. Quattrin added.
For this open-label, randomized, six-month study, investigators
enrolled 335 subjects aged 12 to 65 years who had been diagnosed
with diabetes mellitus for at least one year. They participated
for two months prior to study entry in a stable subcutaneous
insulin regimen with at least two insulin or insulin analog
injections per day.
In the study, 170 patients received insulin delivered as one to
two inhalations of 1 mg and 3 mg before meals, plus one bedtime
injection of Ultralente®. One hundred and sixty-five subjects
received two to three subcutaneous injections insulin or insulin
analog.
The primary efficacy end point was the change in glycemic control
(change in HbA1c) from baseline to week 24.
In
addition, patients using Exubera® showed significantly greater
decreases in both fasting plasma glucose concentrations (a
measurement taken before breakfast) and two-hour post-prandial
glucose levels (a measurement taken after a meal) compared to
patients who took only insulin injections. Patients in both the
Exubera® and multiple injection groups worked with their
physicians during the study to adjust their insulin dose to
optimize blood glucose control.
At week 24, the HbA1c reduction was from 8.1 percent to 7.9
percent in the inhaled insulin group and from 8.1 percent to 7.7
percent in the subcutaneous injection group. Fasting plasma
glucose and two-hour post-prandial glucose readings showed
significantly greater reductions in the inhaled insulin group,
with -35 mg/dL and -30mg/dL for the inhaled insulin group and -10
mg/dL and 1 mg/dL for the subcutaneous insulin group.
A total of 58.0 percent and 15.9 percent respectively reached an
HbA1c level below 8 percent and below 7 percent for the inhaled
insulin group, and 61.9 percent and 15.5 percent respectively for
the subcutaneous insulin group.
A
greater improvement in satisfaction with treatment among patients
treated with inhaled insulin than in those treated with
subcutaneous insulin.
Patients treated with inhaled insulin had a lower risk of
hypoglycemic events (measured in events/subject per month; (8.6)
than did patients treated with subcutaneous insulin (9.0; CI:
0.93. 0.99). The difference in severe events was not significant
(5.5 vs. 4.7 events per 100 subjects per month respectively).
The researchers concluded that inhaled insulin "may provide a
valuable noninvasive therapy for people with type 1
diabetes".
The study was
sponsored by Pfizer Global Research and Development and Inhale
Therapeutic Systems.
