Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs

Mark Peyrot, Richard R. Rubin, William H. Polonsky, H. Jennie

    Research output: Contribution to journalArticle

    Abstract

    Objective: To determine whether treatment satisfaction and quality of life were affected by adding mealtime pramlintide or rapid-acting insulin analogs (RAIAs) to basal insulin therapy for patients with inadequately controlled type 2 diabetes. Research design and methods: In this 24-week open-label, multicenter study of adults with type 2 diabetes, mealtime pramlintide (PRAM) (120g fixed dose; n56) or titrated RAIAs (n56) was added to basal insulin therapy with or without oral antidiabetic medications. Clinical trial registration: ClinicalTrials.Gov NCT00467649 Main outcome measures: Quality of life (Diabetes Distress Scale DDS, and Pittsburgh Sleep Quality Index PSQI), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire DTSQ, and Pramlintide Treatment Satisfaction Questionnaire PRAM-TSQ) were assessed at baseline and week 24. Mixed-effect models estimated mean group changes from baseline to week 24 (adjusted for baseline scores) in patient reported outcomes. Results: PRAM patients experienced significant improvement in total diabetes distress, while RAIA patients did not; both groups experienced significant improvement in regimen-related distress and physician-related distress. Between-group differences in DDS measures were not significant. PRAM patients experienced significant improvement in sleep latency and daytime dysfunction, while RAIA patients did not; the difference between groups was significant for daytime dysfunction. Both treatment groups experienced significant improvement in most individual DTSQ items and total diabetes treatment satisfaction, while only PRAM patients experienced significant improvement in perceived hypoglycemia. Between-group differences in DTSQ measures were not significant. Both treatment groups experienced significant improvement in most individual PRAM-TSQ items and total treatment satisfaction; RAIA patients experienced increased eating flexibility and reduced perceived weight control. PRAM patients experienced significantly better perceived weight and appetite control than RAIA patients. Limitations: The sample size was relatively small and there were few non-white subjects. The schedule for implementation of change in therapy may have affected study outcomes. Conclusions: Adding pramlintide on a background of basal insulin improved some aspects of treatment satisfaction and quality of life relative to adding rapid-acting insulin analogs.

    Original languageEnglish (US)
    Pages (from-to)1047-1054
    Number of pages8
    JournalCurrent Medical Research and Opinion
    Volume26
    Issue number5
    DOIs
    StatePublished - May 1 2010

    Keywords

    • Insulin
    • Pramlintide
    • Quality of life
    • Randomized controlled trial
    • Treatment satisfaction

    ASJC Scopus subject areas

    • Medicine(all)

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