An unresolved problem in the management of
type 2 diabetes is that improvement of
glycemic control with
insulin,
insulin secretagogues, and
insulin sensitizers is often accompanied by undesired
weight gain. This problem is of particular concern in ethnic groups with a high propensity for diabetes and
obesity, such as African Americans and Hispanics. Two 1-year, randomized, double-blind, placebo-controlled clinical trials in
insulin-treated patients with
type 2 diabetes have shown that adjunctive
therapy with
pramlintide, an analog of the human beta-cell
hormone amylin, reduces A(1C) with concomitant
weight loss, rather than
weight gain. To assess the effect of
pramlintide in various ethnic groups with
type 2 diabetes using
insulin, we conducted a pooled post hoc analysis of the 2 trials, which included all Caucasian (n = 315), African American (n = 47), and Hispanic (n = 48) patients (age 57 years, A(1C) 9.1%, body mass index [BMI] 33 kg/m(2), mean values) who completed 52 weeks of treatment with either
pramlintide (120 microg twice daily or 150 microg 3 times a day) or placebo. Primary endpoints included changes from baseline to week 52 in A(1C) and
body weight. Collectively,
pramlintide-treated patients achieved significant reductions from baseline in both A(1C) and
body weight (placebo-corrected treatment effects at week 52: -0.5% and -2.6 kg, respectively, both P <.0001). The simultaneous reduction in A(1C) and
body weight at week 52 was evident across all 3 ethnic groups and appeared to be most pronounced in African Americans (-0.7%, -4.1 kg), followed by Caucasians (-0.5%, -2.4 kg) and Hispanics (-0.3%, -2.3 kg). The glycemic improvement with
pramlintide was not associated with an increased incidence of
hypoglycemia over the entire study period (43%
pramlintide v 40% placebo).
Nausea, the most common adverse event associated with
pramlintide treatment, was mostly mild and confined to the first 4 weeks of
therapy (25%
pramlintide v 16% placebo) with comparable patterns in the 3 ethnic groups. Thus, pending further experience, the combined improvement in glycemic and weight control with
pramlintide treatment appears to be generalizable to a broad population of mixed ethnicity.