Richard R Rubin1, Mark Peyrot. 1. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. rrubin443@aol.com <rrubin443@aol.com>
Abstract
OBJECTIVE: This study was designed to assess treatment satisfaction in patients using pramlintide who had not previously achieved glycemic targets with insulin therapy alone. Assessment included the association between treatment satisfaction and clinical outcomes (changes in post-prandial glucose [PPG], glycosylated hemoglobin [HbA(1c)], weight, and insulin requirements). RESEARCH DESIGN AND METHODS: In this open-label study 240 participants with type 1 diabetes and 160 participants with type 2 diabetes added pramlintide to their established insulin regimen. Mealtime insulin doses were subsequently adjusted to optimize glycemic control. MAIN OUTCOME MEASURES: Seven-point glucose profiles, weight, and insulin requirements were obtained at baseline and months 1, 3, and 6; HbA(1c) levels were obtained at baseline and months 3 and 6. Participants completed a treatment satisfaction questionnaire (TSQ) at months 1, 3, and 6. RESULTS: Participants rated the study treatment regimen including pramlintide significantly (p < 0.001) superior to their pre-study regimens in terms of 'glucose control', 'eating-weight control', and 'general benefits' at all three TSQ administrations. Regression analysis of treatment satisfaction at 6 months revealed several independent predictors (p < 0.05). Participants who were able to reach the maximum dosage of pramlintide per protocol, and those who experienced more reduction in PPG and insulin requirements during the study, reported higher satisfaction with glucose control and general benefits; those who lost more weight reported higher treatment satisfaction on all three TSQ measurements. CONCLUSIONS: Greater satisfaction with the study regimen was reported on all treatment satisfaction factors at all three TSQ administrations, with all advantages representing large treatment effects. Treatment satisfaction was higher for patients who experienced better clinical outcomes (decreases in weight, insulin dose requirements, and PPG levels). Study limitations include the fact this was an open-label study.
OBJECTIVE: This study was designed to assess treatment satisfaction in patients using pramlintide who had not previously achieved glycemic targets with insulin therapy alone. Assessment included the association between treatment satisfaction and clinical outcomes (changes in post-prandial glucose [PPG], glycosylated hemoglobin [HbA(1c)], weight, and insulin requirements). RESEARCH DESIGN AND METHODS: In this open-label study 240 participants with type 1 diabetes and 160 participants with type 2 diabetes added pramlintide to their established insulin regimen. Mealtime insulin doses were subsequently adjusted to optimize glycemic control. MAIN OUTCOME MEASURES: Seven-point glucose profiles, weight, and insulin requirements were obtained at baseline and months 1, 3, and 6; HbA(1c) levels were obtained at baseline and months 3 and 6. Participants completed a treatment satisfaction questionnaire (TSQ) at months 1, 3, and 6. RESULTS:Participants rated the study treatment regimen including pramlintide significantly (p < 0.001) superior to their pre-study regimens in terms of 'glucose control', 'eating-weight control', and 'general benefits' at all three TSQ administrations. Regression analysis of treatment satisfaction at 6 months revealed several independent predictors (p < 0.05). Participants who were able to reach the maximum dosage of pramlintide per protocol, and those who experienced more reduction in PPG and insulin requirements during the study, reported higher satisfaction with glucose control and general benefits; those who lost more weight reported higher treatment satisfaction on all three TSQ measurements. CONCLUSIONS: Greater satisfaction with the study regimen was reported on all treatment satisfaction factors at all three TSQ administrations, with all advantages representing large treatment effects. Treatment satisfaction was higher for patients who experienced better clinical outcomes (decreases in weight, insulin dose requirements, and PPG levels). Study limitations include the fact this was an open-label study.