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Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.


ABSTRACT: AIMS:To assess the effects on glycaemic control of lixisenatide vs placebo as add-on treatment to basal insulin (BI)?±?metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D). METHODS:Patients (n?=?448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI?±?metformin for 24?weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6?mmol/L). The primary endpoint was absolute change in HbA1c from baseline to week 24. Secondary efficacy endpoints included: percentage of responders; changes in 2-hour postprandial plasma glucose (PPG); 7-point SMPG (daily average); body weight (BW); total daily BI dose; fasting plasma glucose; and safety assessments. RESULTS:Baseline demographics were similar in the two treatment groups. After insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change -0.62% [0.09] vs -0.11% [0.09]; P?

SUBMITTER: Yang W 

PROVIDER: S-EPMC5813270 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.

Yang Wenying W   Min Kyungwan K   Zhou Zhiguang Z   Li Ling L   Xu XiangJin X   Zhu Dalong D   Venkateshwar Rao A A   Murthy Laxminarayanappa Sreenivasa LS   Zhang Nianxian N   Li Ivy I   Niemoeller Elisabeth E   Shang Shuhua S  

Diabetes, obesity & metabolism 20171005 2


<h4>Aims</h4>To assess the effects on glycaemic control of lixisenatide vs placebo as add-on treatment to basal insulin (BI) ± metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D).<h4>Methods</h4>Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored  ...[more]

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