Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

本项治疗时长为26周的3b期、随机、开放标签、平行组、阳性对照多中心目标导向治疗（treat-to-target）研究，旨在评估每周一次的阿必鲁肽（albiglutide）替代餐时胰岛素，用于当前基础-餐时胰岛素治疗方案（联合或不联合二甲双胍）未获得充分血糖控制的2型糖尿病（T2DM）受试者的有效性与安全性。计划将约794名受试者按1:1比例随机分配至两个治疗组之一：阿必鲁肽联合甘精胰岛素组（第4周停用赖脯胰岛素，联合或不联合二甲双胍），或甘精胰岛素联合赖脯胰岛素剂量强化组（联合或不联合二甲双胍）。本研究共包含4个研究阶段：筛选期（2周）、标准化期（4周）、治疗期（26周）以及治疗后随访期（4周）。受试者的总参与时长约为36周。