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Objective: In this pooled analysis, the efficacy and tolerability of exenatide once weekly (EQW) in patients categorized by baseline concomitant glucose-lowering therapy were evaluated., Methods: This post hoc analysis included data from the intent-to-treat populations of 7 randomized controlled trials in which patients with type 2 diabetes mellitus were treated with EQW for 24 to 30 weeks. Patients were classified into subgroups on the basis of their baseline glucose-lowering therapy: diet and exercise only, metformin (MET) only, MET + sulfonylurea (SU), SU ± other (thiazolidinedione [TZD] only or MET + TZD), or TZD ± MET. Changes from baseline in key efficacy endpoints and tolerability were analyzed by baseline concomitant glucose-lowering therapy group., Results: A total of 1719 patients were included. Treatment with EQW was associated with significant improvements from baseline in glycated hemoglobin levels, fasting glucose levels, and body weight in all of the groups. There were significant decreases from baseline for both systolic blood pressure and diastolic blood pressure in the MET and MET + SU groups, and a significant decrease in systolic blood pressure in the diet and exercise group. Lipid profiles generally improved in the diet and exercise, MET only, MET + SU, and TZD ± MET groups. Overall, the most frequent adverse events with EQW treatment, other than hypoglycemia, were nausea (14.7%), diarrhea (10.9%), and nasopharyngitis (7.2%). There was a higher incidence of hypoglycemia when EQW was added to regimens that included an SU., Conclusion: The addition of EQW for 24 to 30 weeks to regimens that included a wide variety of background glucose-lowering therapies was associated with significant improvements in glycemic control and weight loss. The tolerability profile of EQW appeared to be similar regardless of background therapy, except for a higher incidence of minor hypoglycemia when EQW was added to regimens that included an SU.

Background: Exenatide, a glucagon-like peptide-1 receptor agonist, is used twice daily (BID) as monotherapy or adjunctive therapy for the improvement of glycemic control in patients with type 2 diabetes mellitus. The purpose of this pooled analysis was to evaluate the safety and efficacy of exenatide BID in patients stratified by various demographic characteristics., Methods: This post hoc analysis included data from 16 randomized controlled trials in which patients with type 2 diabetes mellitus were treated with 10-μg exenatide BID. Each patient was classified into subgroups on the basis of his or her baseline values for age (< 65 or ≥ 65 years), sex (male or female), race (white, black, Asian, or Hispanic), duration of diabetes (< 10 years or ≥ 10 years), and body mass index (BMI; ≥ 20 to < 25, ≥ 25 to < 30, ≥ 30 to < 35, or ≥ 35 kg/m(2))., Results: A total of 2067 patients were included. All groups experienced significant improvements in glycated hemoglobin, fasting plasma glucose levels (other than black patients, who had a relatively low baseline fasting plasma glucose level), and body weight from baseline to endpoint. Most groups had significant improvements in systolic blood pressure. All of the age, sex, and duration of diabetes groups experienced significant improvements in lipid levels (other than high-density lipoprotein cholesterol). Whites and Asians generally experienced significant improvements in lipid levels, whereas blacks and Hispanics did not. Significant improvements in lipid levels were generally seen across BMI groups. The most common adverse events overall were nausea (38.6%), hypoglycemia (28.4%), and vomiting (14.0%). Hypoglycemia was more common overall in patients who were taking a concomitant sulfonylurea than it was in patients who were not., Conclusion: In this pooled analysis, exenatide BID improved glycemic control and body weight, and had generally beneficial effects on blood pressure and lipid levels in patients regardless of baseline age, sex, race, duration of diabetes, or BMI. Gastrointestinal events were the most common adverse events., Trial Registration: www.ClinicalTrials.gov [NCT00039026, NCT00039013, NCT00082381, NCT00035984, NCT00082407, NCT00381342, NCT00360334, NCT00375492, NCT00603239, NCT00765817, NCT00577824, NCT00434954].