Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes.

AIMS/INTRODUCTION: We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss. MATERIALS AND METHODS: This prospective, observational, single-arm (exenatide b.i.d. in combination with both metformin and sulphonylurea), open-label study of GLP-1 analog treatment with close monitoring of metabolic parameters and weight changes was carried out for up to 22 weeks. RESULTS: Of the 110 enrolled obese participants, 37 participants dropped out during the 22-week treatment period. A total of 73 participants completed the study (median age 55.0 years, interquartile range 44.0-65.0). The median duration of diabetes was 8.0 years (interquartile range 3.5-12.5) with a mean HbA1c value of 7.6% (interquartile range 7.00-8.55). The median body mass index was 30.78 kg/m(2) (interquartile range 27.89-33.92). After 22 weeks, median changes from baseline for HbA1c levels and weight were -0.7% and -3.0 kg, respectively, which were significant. No severe hypoglycemic events were observed. Multivariate regression analysis showed that C-peptide values were a significant independent predictor for a reduction in HbA1c levels (β = 0.865, P = 0.018) with exenatide BID in combination with both sulphonylurea and metformin in obese Korean participants with type 2 diabetes and insulin naïveté. CONCLUSIONS: Clinical and laboratory parameters, such as insulin naïveté and preserved β-cell function, should be taken into consideration as important factors in the choice of GLP-1 analog when predicting GLP-1 analog responsiveness. This trial was registered with the local committee at Yonsei University in Korea (4-2011-0032).