Aims: This study assessed patient-reported outcomes in a multicenter study of adults with type 2 diabetes taking mealtime Technosphere(®) inhaled insulin (MannKind Corp., Valencia, CA) and basal insulin (insulin glargine) or premixed aspart insulin 70/30.
Methods: Subjects were 618 non-smoking adults with starting hemoglobin A1c >7.0%: 302 in the Technosphere+glargine (TI+G) arm and 316 in the biphasic rapid-acting insulin arm (premixed aspart insulin 70/30). Subjects (47% male; mean age, 56 years; mean duration of diagnosed diabetes, 13.4 years) completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Inhaled Insulin Treatment Questionnaire [IITQ]) before starting insulin treatment and approximately 45 weeks later.
Results: There were no significant changes in either treatment arm for SF-36 Physical or Mental Component Summary measures. IITQ Diabetes Worries declined significantly in the TI+G arm (P=0.008), and Perceptions of Insulin Therapy, Treatment Satisfaction, and Treatment Preference improved in both arms (all P<0.001); there were no significant between-arm differences in change on any of these measures.
Conclusions: Treatment with inhaled Technosphere insulin was implemented without a negative impact on health-related quality of life and with a reduction in diabetes worries. Improvements in perceptions of insulin therapy, treatment satisfaction, and treatment preference did not differ from treatment with premixed aspart insulin.
Trial registration: ClinicalTrials.gov NCT00309244.