A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes

A Randomized Study and Open-Label Extension Evaluating the Long-Term Efficacy of Pramlintide as an Adjunct to Insulin Therapy in Type 1 Diabetes Fred Whitehouse , MD 1 , Davida F. Kruger , MSN 1 , Mark Fineman , BS 2 , Larry Shen , PHD 2 , James A. Ruggles , PHD 2 , David G. Maggs , MD 2 , Christian Weyer , MD 2 and Orville G. Kolterman , MD 2 1 Henry Ford Hospital, Detroit, Michigan 2 Amylin Pharmaceuticals, San Diego, California Abstract OBJECTIVE —To assess the effect of mealtime amylin replacement with pramlintide on long-term glycemic and weight control in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS —In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 μg pramlintide q.i.d., in addition to existing insulin regimens. At week 20, pramlintide-treated patients were re-randomized to 30 or 60 μg pramlintide q.i.d. if decreases from baseline in HbA 1c were