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Treatment was also associated with a significant reduction in body weight of 1.45 kg and a 2- to 3-fold increase in the percentage of patients losing 2.5% and 5% of their body weight.
Adjunctive therapy with pramlintide improves glycemic control in conjunction with weight loss in insulin-treated type 2 diabetics, according to researchers.
Pramlintide is a human amylin analog that is in late stage clinical development as an adjunct to insulin therapy for both type 1 and 2 diabetics.
Dr. Christian Weyer, with Amylin Pharmaceuticals, Inc., in San Diego, California, presented study results on August 25th at the Eighteenth International Diabetes Federation (IDF) Congress, of a pooled post-hoc analysis of two long-term, randomized, double-blind, placebo-controlled pivotal trial.
Subjects in both trials were patients with type 2 diabetes who were treated with insulin alone or in combination with sulfonylureas and or metformin.
The present analysis included all those subjects who were overweight or obese at baseline (defined as a body mass index greater than 25 kg/m2) and had been assigned to pramlintide 120 ug BID or placebo dosing regimens, and had completed 26 weeks of treatment.
Adjunctive treatment with pramlintide resulted in a significant reduction (P < 0.0001) in hemoglobin A1C of 0.59% compared to 0.18% for placebo, and a reduction in total daily insulin use of 0.2 U compared to an increase of 4.1 U for placebo.
Treatment was also associated with a significant reduction in body weight of 1.45 kg compared to a gain of 0.31 for placebo and a 2- to 3-fold increase in the percentage of patients losing 2.5% and 5% of their body weight.
The weight reduction with pramlintide treatment was most pronounced in markedly obese patients and was not "simply attributable" to the occurrence of nausea in some subjects.
Pramlintide was generally well tolerated.
Dr. Weyer said that the findings are promising but emphasised that additional studies are needed to examine pramlintide’s effect on satiety and eating behaviour and on body weight when used in conjunction with lifestyle intervention.
The study was sponsored by Amylin Pharmaceutical, Inc. in San Diego, California.
IDF: [Study title: The human Amylin analog, pramlintide, reduces body weight in insulin-treated patients with type 2 diabetes. Abstract 852]
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DID YOU KNOW: Cardiovascular Disease is Risk Factor for Erectile Dysfunction in Diabetic Men: Forty seven percent of diabetic men with cardiovascular disease had severe erectile dysfunction compared with 25% of diabetic men without cardiovascular disease.
Diabetic men with cardiovascular disease seem to be at increased risk of erectile dysfunction.
IDF: [Study title: Cardiovascular Disease (CVD) in diabetic men: a significant risk marker for Erectile Dysfunction (ED). Abstract 1437]