Effect of technosphere inhaled insulin on quality of life and treatment satisfaction

Aims: This randomized controlled trial assessed the impact of Technosphere^® insulin (MannKind Corp., Valencia, CA) delivered via the MedTone^® inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes. Methods: Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance. Results: There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure=0.56, P=0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median=93% positive ratings). Conclusions: In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes.