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

  1. David G. Marrero, PHD1,
  2. John Crean, PHD2,
  3. Bei Zhang, MD2,
  4. Terrie Kellmeyer, PHD2,
  5. Maurice Gloster, MD2,
  6. Kathrin Herrmann, PHD2,
  7. Richard Rubin, PHD3,
  8. Naomi Fineberg, PHD1 and
  9. Orville Kolterman, MD2
  1. 1Department of Endocrinology and Metabolism, Indiana University School of Medicine, Indianapolis, Indiana
  2. 2Amylin Pharmaceuticals, San Diego, California
  3. 3Department of Medicine and Pediatrics, Johns Hopkins University, Baltimore, Maryland
  1. 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

Abstract

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.

Footnotes

  • D.G.M. has received honoraria from and has been on an advisory board for Amylin Pharmaceuticals. R.R. has been a member of an advisory panel for and has received grant/research support from Amylin Pharmaceuticals.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

    • Accepted October 24, 2006.
    • Received May 18, 2006.
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