approaching the levels seen in normal people, which are believed to be
an important risk factor in the development of complications from the
-- The ability to achieve comparable levels of overall glucose control
compared with present "state of the art" treatment, as measured by
HbA1c, which is considered the standard measure of a treatment's
effectiveness in diabetes.
-- A lower risk of hypoglycemia, which is considered to be a major problem
for patients using presently available insulins and many oral
treatments, limiting their ability to optimally treat their disease.
-- No weight gain and even weight loss in patients treated with
Technosphere(R) Insulin, in contrast to the weight gain that is usually
considered a major downside of insulin therapy for many patients.
-- No need for complex meal titration, as utilized in our studies to date,
significantly simplifying treatment and reducing the training typically
needed for insulin therapy.
-- No adverse effect on the measures of pulmonary function that have been
reported to occur with other inhaled insulins.
Even with these advantages over existing insulin therapy, MannKind
understands that physicians and regulatory agencies are cautious about a
new route of administration. For this reason, MannKind is conducting a very
robust clinical trial program involving more than 5,000 patients with
diabetes, which it determined is consistent with the FDA's recently
released guidance for the development of drugs to treat diabetes. As part
of this program, a 2,050-patient, two-year pulmonary safety trial will
conclude later this year; this trial was recently recognized by the
American Association of Respiratory Care as setting new quality standards
in the conduct of clinical studies. In the interim, all of MannKind's
clinical trials are monitored by an indep
|SOURCE MannKind Corporation|
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