Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes - A 1-year randomized controlled trial

Objective-Mealtime amylin replacement with the human amylin analog pramlintide, as an adjunct to mealtime insulin replacement, reduces postprandial glucose excursions in patients with type 2 diabetes. The aim of the present study was to assess the long-term efficacy and safety of pramlintide in this patient population. Research Design and Methods-In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 7+/-10 years, diabetes duration 12+/-7 years, BMI 34.0+/-7.0 kg/m(2), HbA(1c) 9.1+/-1.2%, mean+/-SD) treated with insulin (alone or in combination with sulfonylureas and/or metformin) were randomized to receive additional preprandial subcutaneous injections of either placebo or pramlintide (60 mug TID, 90 mug BID, or 120 mug BID). Results-Treatment with pramlintide 120 mug BID led to a sustained reduction from baseline in HbA(1c) (-0.68 and -0.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P<0.05). The proportion of patients achieving an Hb(A1c) <8% was approximately twofold greater with pramlintide (120 mug BID) than with placebo (46 vs. 28%, P<0.05). The glycemic improvement with pramlintide 120 mu g BID was accompanied by a mean weight loss (-1.4 kg vs. +0.7 kg with placebo at week 52, P<0.05) and occurred without an overall increase in the severe hypoglycemia event rate. The most common adverse event associated with pramlintide use was transient, mild-to-moderate nausea. Conclusions-Mealtime amylin replacement with pramlintide 120 mug BID as an adjunct to insulin therapy, improves long-term glycemic and weight control in patients with type 2 diabetes.