Effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes.

Marrero, David G; Crean, John; Zhang, Bei; Kellmeyer, Terrie; Gloster, Maurice; Herrmann, Kathrin; Rubin, Richard; Fineberg, Naomi et al. · Diabetes Care · 2007

rct · Level II

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Abstract

To assess the effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes treated with intensive insulin regimens. 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. 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%). Despite similar reductions in A1C, pramlintide treatment resulted in greater treatment satisfaction compared with placebo treatment. This was independent of insulin delivery method.

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