Exenatide once weekly for the treatment of type 2 diabetes: effectiveness and tolerability in patient subpopulations

Abstract

ObjectivePatient numbers in individual diabetes trials are often too limited to assess the effect of a treatment by different patient characteristics, and meta-analyses often do not include patient-level data. The purpose of this pooled analysis was to evaluate the efficacy and tolerability of exenatide once weekly (EQW) in patients with type 2 diabetes grouped into subpopulations by key demographic characteristics.MethodsThis post hoc analysis included data from patients who received EQW in seven randomised, controlled phase 3 trials that were 24–30 weeks in duration. Patients were classified into subpopulations on the basis of their baseline age (< 65 or ≥ 65 years), gender (male or female), race (White, Black, Asian, Hispanic), duration of diabetes (< 10 years, ≥ 10 years) and body mass index (BMI; < 25, ≥ 25 to < 30, ≥ 30 to < 35, ≥ 35 to < 40 or ≥ 40 kg/m2).ResultsA total of 1719 patients were included in this analysis of patient subpopulations. All subpopulations experienced significant improvements from baseline in haemoglobin A1C, fasting glucose and body weight. Most subpopulations experienced significant improvements in blood pressure and lipid parameters. Overall, the most common AEs were hypoglycaemia (16.4% overall; 2.3% in patients not on concomitant sulfonylurea), nausea (14.7%), diarrhoea (10.9%) and nasopharyngitis (7.2%).ConclusionThese results show that the treatment of type 2 diabetes with EQW for 24–30 weeks was associated with significant improvements in glycaemic control and body weight, irrespective of age, gender, race, duration of diabetes or BMI. The most common adverse events were gastrointestinal in nature.

Similar efficacy and safety of once‐weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years

“…Nausea, the most common adverse event, was transient; with the highest rates in the first 2 weeks, rapidly declining thereafter. The dulaglutide results from this analysis are consistent with other published studies that show no difference in efficacy and safety of GLP‐1 receptor agonist use in older patients with T2D compared with younger patients .…”

Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

“…These findings (similar improvements in HbA1c for both sexes) were consistent with results observed in studies of exenatide BID and QW [3,4].…”

“…Dulaglutide-and liraglutide-treated females in our analysis had both greater mean weight loss and greater incidence of gastrointestinal events compared to males (one group of dulaglutide-treated males had mean weight gain), and these results were similar to those observed in subgroup analyses of data from clinical trials of exenatide BID and QW [3,4]. Patients in the dulaglutide and liraglutide groups in the monotherapy study experiencing certain key gastrointestinal events (17% to 18% of patients in each group) had greater mean weight loss than patients not experiencing any of the events (Table 5), but the effect of sex on the relationship between occurrence of gastrointestinal events and changes in weight was unclear.…”

“…In subgroup analyses using data from clinical trials of exenatide twice daily (BID) and exenatide once weekly (QW), similar changes from baseline in glycated hemoglobin (HbA1c) were observed in both males and females, and greater weight loss was observed in females compared to males [3,4]. In another study, females treated with exenatide BID and metformin experienced greater reductions in HbA1c and weight compared to males [5].…”

Weight Management in Type 2 Diabetes: Current and Emerging Approaches to Treatment

“…Major hypoglycemia was reported only when liraglutide was used in combination with a sulfonylurea. Similarly, exenatide once-weekly has been studied in combination with other antihyperglycemic agents with study durations of 24-30 weeks (52). In combination with metformin, metformin plus sulfonylurea, sulfonylurea with or without TZD, or metformin plus TZD, treatment with exenatide once-weekly led to significant improvements from baseline in HbA 1c levels and body weight with all combinations.…”