Objective: This study was designed to assess the safety and efficacy of pramlintide therapy in patients with type 2 diabetes in a clinical practice setting.
Methods: In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%. Insulin doses were subsequently adjusted to optimize glycemic control. Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
Results: At 6 months, the change in A1C from baseline (8.3%) was -0.56% (P < 0.05; n = 59). Pramlintide treatment significantly reduced mean postprandial glucose excursions (P < 0.05) and weight (-2.8 kg; P < 0.05; n = 125). Glycemic benefits were achieved with lower mealtime insulin doses (-10.3%; P < 0.05; n = 104). Nausea, primarily mild to moderate, was reported by 29.5% of patients (severe nausea in 2.4%). Rates of severe hypoglycemia were low (0.04 events/patient-year).
Conclusions: In this uncontrolled, open-label setting, pramlintide initiation while reducing mealtime insulin, followed by insulin dose optimization, resulted in improvements in postprandial glucose excursions and A1C. These improvements in glycemic control were accompanied by weight loss.
Trial registration: ClinicalTrials.gov NCT00108004.