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Item
#6
Pramlintide
Helpful Adjunct to Insulin in Type 2 Diabetics
Pramlintide
a valuable addition to the arsenal of therapies available
to patients with type 2 diabetes.
Mealtime amylin replacement with pramlintide as adjunctive therapy to
insulin improves glycemic control and weight in type 2 diabetics,
according to the results of a one-year randomized controlled trial
published in the March issue of Diabetes Care.
"Mealtime
amylin replacement with the human amylin analog pramlintide, as an
adjunct to mealtime insulin replacement, reduces postprandial glucose
excursions in patients with type 2 diabetes," write Priscilla A.
Hollander, MD, from Baylor University Medical Center in Dallas, Texas,
and colleagues.
In
this double-blind, placebo-controlled, parallel-group, multicenter
study, 656 patients with type 2 diabetes requiring insulin treatment
were randomized to receive additional preprandial subcutaneous
injections of either placebo or pramlintide, 60 µg three times daily,
90 µg twice daily, or 120 µg twice daily. At study entry, mean age
was 57 ± 10 years, diabetes duration was 12 ± 7 years, BMI was 34.0
± 7.0 kg/m2,
and HbA1c
was 9.1 ± 1.2%. Subjects had been treated with insulin alone or in
combination with sulfonylureas and/or metformin.
In
patients treated with pramlintide 120 µg twice daily, there was a
sustained reduction from baseline in HbA1c
of –0.68% at week 26 and –0.62% at week 52, which was
significantly greater than that seen with placebo (P < .05).
The proportion of patients achieving a HbA1c
below 8% was 46% with pramlintide, 120 µg twice daily, and 28% with
placebo (P < .05). At week 52, weight control was also
better in patients receiving pramlintide, 120 µg twice daily, than in
those receiving placebo (weight change –1.4 kg vs. +0.7 kg; P
< .05), even though there was no overall increase in the rate of
severe hypoglycemic events. The most common adverse event reported
with pramlintide use was transient, mild-to-moderate nausea.
"Mealtime
amylin replacement with pramlintide 120 µg BID, as an adjunct to
insulin therapy, improves long-term glycemic and weight control in
patients with type 2 diabetes," the authors write.
"Importantly, the improvement in glycemic control with
pramlintide was accompanied by a mean reduction in body weight and no
overall increase in severe hypoglycemia. Because of these unique and
desirable clinical benefits, pramlintide may become a valuable
addition to the arsenal of therapies available to patients with type 2
diabetes."
Amylin
Pharmaceuticals, Inc., employs one of this study's authors and has
financial arrangements with other study authors.
Diabetes
Care. 2003;26:784-790
===========================
DID
YOU KNOW:
Young women
with type 1 diabetes are 30 times more likely than other women their
age to die of heart disease. Young
women with type 1 (insulin-dependent) diabetes face a huge heart risk.
They are 30 times more likely than other women their age to die of
heart disease. This is according to a report presented at a diabetes
meeting in Glascow, Scotland.
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