ADA: Pramlintide Added to Intensive
Insulin Regimen in Type 1 Diabetics
Pramlintide when added to an intensified insulin
regimen using dose-titration, resulted in manageable
side effects and less need for short-acting insulin.
Their findings at the 63rd Scientific Sessions
of the American Diabetes Association,
also showed that this approach maintains the glycemic
and weight benefits seen in previous studies.
Dr. Orville Kolterman, from Amylin Pharmaceuticals,
in San Diego, California, presented interim 16-week
data from a triple-blind, 29-week study that determined
whether pramlintide dose-titration at 15, 30,
45, and 60 mcg, with a temporary decrease in short-acting
preprandial insulin, helps prevent transient nausea
and the increased risk of severe hypoglycemia
previously seen in type 1 diabetes patients.
The study included 295 type 1 diabetics who underwent
intensive insulin therapy by multiple daily injections
or insulin pump therapy for more than 6 months
of screening. Subjects were randomized to pramlintide
or placebo maintenance therapy at 30mcg or 60
mcg, with insulin doses intensively adjusted to
optimize glycemic control.
Upon completion of 29 weeks of therapy, about
80% of pramlintide-treated subjects were at the
60-mcg dose and about 20% were at the 30-mcg dose.
In addition, pramlintide-treated subjects had
a greater reduction in short-acting preprandial
insulin use and a smaller increase in basal insulin
use compared to placebo.
A pramlintide-associated decrease in postprandial
glucose concentrations was observed during formal
standardized meal tests as well as during self-monitored
glucose measurements. This effect was sustained
throughout 29 weeks of pramlintide therapy.
A similar decrease in mean hemoglobin A1C from
baseline was achieved by pramlintide- and placebo-treated
subjects after 29 weeks of therapy. In addition,
pramlintide-treated patients showed a significant
and persistent decrease in mean body weight throughout
the duration of the trial.
A higher incidence of nausea was observed among
pramlintide patients compared to placebo. As expected,
the incidence of nausea decreased at each subsequent
pramlintide dose level (from 35.1% at 15 mcg to
8.2% at 60 mcg.
Among pramlintide-treated subjects, 1.4% withdrew
because of nausea compared to 0.7% in the placebo-treated
group.
The severe hypoglycemia event rate per subject
year was lower in the present study during the
pramlintide initiation and insulin dose optimization
periods compared to previous long-term clinical
trials.
The severe hypoglycemia event rate seen in treated
patients was comparable to that observed in the
intensive-insulin group of the Diabetes Control
and Complications Trial (DCCT).
"Our results show that in type 1 diabetics
treated with intensive insulin therapy and approaching
glycemic targets, pramlintide can be successfully
added to the insulin regimen, by pramlintide dose-titration
in conjunction with a reduction in short-acting
insulin," Dr. Kolterman said. The study was
sponsored by Amylin Pharmaceuticals.
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