Effect of pramlintide on A1C and body weight in insulin-treated African Americans and Hispanics with type 2 diabetes: a pooled post hoc analysis
Section snippets
Study design
The designs of the 2 long-term, randomized, placebo-controlled, double-blind studies included in this pooled post hoc analysis have been described in detail previously.24, 25 In brief, both studies included patients with type 2 diabetes and utilized an add-on design, ie, pramlintide or placebo (injected subcutaneously twice daily or 3 times a day before the major meals) were added to pre-existing insulin regimens. Study medication (placebo or pramlintide), but not insulin or oral medications,
Patient disposition and baseline demographics
Of the 1,194 patients enrolled in the 2 studies, 410 (34%) were randomized to either placebo or pramlintide (120 μg twice daily and 150 μg 3 times a day) and had completed the study. Of those, 315 (77%) were Caucasian, 47 (11%) were African American, and 48 (12%) were Hispanic (Table 1).
Among the 3 ethnic groups, most of the key baseline demographics were well balanced. However, African Americans and Hispanics had a slightly higher mean baseline A1C than Caucasians, and African Americans also
Discussion
It is well established that there are substantial ethnic differences in the prevalence and pathophysiology of type 2 diabetes. However, little is known about potential ethnic differences in the response to different antihyperglycemic therapies. The aim of the present post hoc analysis was to assess the long-term effect of pramlintide, an amylin analog in late-stage clinical development, on both A1C and body weight in insulin-treated African Americans and Hispanics with type 2 diabetes, 2 ethnic
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