Riddle M, Pencek R, Charenkavanich S, Lutz K, Wilhelm K, Porter L
Randomized Comparison of Pramlintide or Mealtime Insulin Added to Basal Insulin Treatment for Patients With Type 2 Diabetes. [JOURNAL ARTICLE]
Diabetes Care 2009 Jun 5.
Objective: To compare the efficacy and safety of adding mealtime pramlintide or rapid-acting insulin analogues (RAIA) to basal insulin for patients with inadequately controlled type 2 diabetes. Research design and methods: In a 24-week open-label, multicenter study, 113 patients were randomized 1:1 to addition of mealtime pramlintide (120 mug) or titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OAD). At screening, patients were insulin-naïve or on <50U/day basal insulin for <6 months. Basal insulin dosage was titrated from Day 1 seeking fasting plasma glucose (FPG)>/=70 to <100mg/dL. Pramlintide and RAIA were initiated on Day 1 and Week 4, respectively. Proportion of patients achieving A1C</=7.0% without weight gain or severe hypoglycemia at Week 24 was the primary endpoint.
Results: More pramlintide- than RAIA-treated patients achieved the primary endpoint (30% vs. 11%, p=0.018) on a similar dose of basal insulin. Pramlintide and RAIA yielded similar mean (+/-SE) values for FPG and A1C at 24 weeks (122+/-7 vs. 123+/-5 mg/dL; 7.2+/-0.2 vs. 7.0+/-0.1%) and similar least-squares mean reductions from baseline to endpoint (-31+/-6 vs. -34+/-6 mg/dL;-1.1+/-0.2% vs. -1.3+/-0.2%). RAIA but not pramlintide caused weight gain (+4.7+/-0.7kg vs. +0.0+/-0.7 kg; p<0.0001). Fewer patients reported mild to moderate hypoglycemia with pramlintide than RAIA (55% vs. 82%) but more patients reported nausea (21% vs. 0%). No severe hypoglycemia occurred in either group.
Conclusions: In patients taking basal insulin and OAD, premeal fixed-dose pramlintide improved glycemic control as effectively as titrated RAIA. The pramlintide regimen sometimes caused nausea but no weight gain and less hypoglycemia.
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