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Diabetes Care 30:210-216, 2007
DOI: 10.2337/dc06-1026
© 2007 by the American Diabetes Association
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Clinical Care/Education/Nutrition
Original Article

Effect of Adjunctive Pramlintide Treatment on Treatment Satisfaction in Patients With Type 1 Diabetes

David G. Marrero, PHD1, John Crean, PHD2, Bei Zhang, MD2, Terrie Kellmeyer, PHD2, Maurice Gloster, MD2, Kathrin Herrmann, PHD2, Richard Rubin, PHD3, Naomi Fineberg, PHD1 and Orville Kolterman, MD2

1 Department of Endocrinology and Metabolism, Indiana University School of Medicine, Indianapolis, Indiana
2 Amylin Pharmaceuticals, San Diego, California
3 Department of Medicine and Pediatrics, Johns Hopkins University, Baltimore, Maryland

Address correspondence and reprint requests to David Marrero, Department of Endocrinology and Metabolism, Indiana University School of Medicine, Indianapolis, IN 46202. E-mail: dgmarrer{at}iupui.edu

OBJECTIVE—To assess the effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes treated with intensive insulin regimens.

RESEARCH DESIGN AND METHODS—Intensively treated (multiple daily injection [MDI] or continuous subcutaneous insulin infusion [CSII] pump therapy) patients with type 1 diabetes completed a study-specific treatment satisfaction questionnaire following 29 weeks of either placebo (n = 136) or pramlintide (n = 130) treatment in a double-blind, noninferiority pramlintide dose titration trial. End points included patient reported outcomes, their relationship to insulin treatment regimen, A1C, weight, and insulin use.

RESULTS—Pramlintide-treated patients reported greater treatment satisfaction in most questionnaire responses. Treatment satisfaction was similar for pramlintide-treated patients regardless of intensive insulin regimens (MDI versus CSII). Mean A1C was reduced to a similar degree in both pramlintide- (–0.39 ± 0.07%) and placebo-treated (–0.45 ± 0.07%) patients. However, pramlintide treatment was associated with reductions in mean body weight (–1.50 ± 0.33 kg; P < 0.0001) and mealtime insulin use (–19.05 ± 5.17%; P < 0.005) over 29 weeks, while placebo treatment resulted in weight gain (1.28 ± 0.25 kg) and a smaller reduction in mealtime insulin use (–2.20 ± 3.33%).

CONCLUSIONS—Despite similar reductions in A1C, pramlintide treatment resulted in greater treatment satisfaction compared with placebo treatment. This was independent of insulin delivery method.

Abbreviations: CSII, continuous subcutaneous insulin infusion • MDI, multiple daily injections


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