Exenatide Twice Daily: Analysis of Effectiveness and Safety Data Stratified by Age, Sex, Race, Duration of Diabetes, and Body Mass Index

Abstract

www.ClinicalTrials.gov [NCT00039026, NCT00039013, NCT00082381, NCT00035984, NCT00082407, NCT00381342, NCT00360334, NCT00375492, NCT00603239, NCT00765817, NCT00577824, NCT00434954].

Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes

“…Subgroup analyses by age groups are the most commonly reported: analyses for liraglutide, exenatide twice daily, exenatide once weekly, and lixisenatide have been published [11,[13][14][15]. In this analysis of dulaglutide studies, elderly patients (≥65 years) had significantly greater reductions in HbA1c, significantly higher incidence of hypoglycemia, and significantly smaller increases in pulse rate compared to younger patients.…”

“…The proportions of patients reporting minor hypoglycemia were low and appeared comparable between the age groups. In a posthoc analysis of 16 randomized studies of exenatide twice daily [13], the changes from baseline in HbA1c and fasting plasma glucose were similar between the age groups, but greater weight loss was observed for elderly patients (≥65 years) compared to younger patients. In a posthoc analysis of 7 randomized studies of exenatide once weekly [14], changes from baseline in HbA1c, fasting plasma glucose, and body weight were similar for both age groups (<65, ≥65 years).…”

“…This is the first analysis of dulaglutide across subgroups; these stratification factors have also been used in previous pooled subgroup analyses for other GLP-1 receptor agonists, such as liraglutide [11,12], exenatide twice daily [13], exenatide once weekly [14], and lixisenatide [15].…”

Efficacy and safety analyses across 4 subgroups combining low and high age and body mass index groups in Japanese phase 3 studies of dulaglutide 0.75 mg after 26 weeks of treatment

“…Therefore, to gain further insight from these data, for this analysis we selected 2 patient characteristics which are always collected during treatment of patients with T2D: age (<65 [young] ). These characteristics have previously been used for subgroup analyses of patients treated with liraglutide, exenatide twice daily, exenatide once weekly, and lixisenatide [16][17][18][19].…”

Therapy of Type 2 Diabetes Mellitus in Elderly Patients: Risks and Prospects

“…Специальный анализ объединенных данных 16 рандомизированных контролируемых исследо-ваний продолжительностью 12-30 нед, которые включали 2067 пациентов с СД2, получавших экзе-натид (10 мг 2 раза в день), продемонстрировали сопоставимое улучшение гликемического контроля у пациентов в возрасте <65 лет (n = 1613), а также лиц в возрасте от 65 лет и старше (n = 454); сред-нее снижение HbA 1c составило -0,9% у молодых пациентов и -1,0% у больных пожилого возраста (р < 0,0001). Гипогликемия наиболее часто отмеча-лась среди пациентов, принимающих препараты СМ (возраст <65 лет, 27,7%; 65 лет и старше, 30,2%), в отличие больных, не получающих такой терапии (возраст <65 лет, 4,0%; 65 лет и старше, 1,2%) [50].…”