Open AccessGetGoal‐O研究中老年2型糖尿病患者使用基础胰岛素加利西那肽治疗的有效性与安全性
Author(s) -
Dailey George E.,
Dex Terry A.,
Roberts Michelle,
Liu Minzhi,
Meneilly Graydon S.
Publication year - 2019
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12952
Subject(s) - lixisenatide , medicine , postprandial , placebo , hypoglycemia , type 2 diabetes , renal function , adverse effect , diabetes mellitus , clinical endpoint , endocrinology , randomized controlled trial , insulin , exenatide , alternative medicine , pathology
Background This study compared the efficacy and safety of lixisenatide with placebo as add‐on therapy to basal insulin (BI) in adults aged ≥70 years with type 2 diabetes (T2D), with or without moderate renal insufficiency. Methods This post hoc analysis evaluated data from non‐frail patients with T2D inadequately controlled on BI with or without oral antidiabetic drugs (n = 108), randomized to once‐daily lixisenatide 20 μg or placebo for 24 weeks (GetGoal‐O Study). The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included changes from baseline in fasting plasma glucose, 2‐hour postprandial plasma glucose (PPG), average seven‐point self‐monitored plasma glucose (SMPG), area under the curve for SMPG, daily BI dose, body weight, proportion of patients achieving HbA1c > 0.5%, and composite endpoints. Safety outcomes included the incidence of documented symptomatic hypoglycemia (plasma glucose <60 mg/dL) and gastrointestinal treatment‐emergent adverse events (TEAEs). Outcomes were also analyzed by the occurrence of moderate renal insufficiency. Results Compared with placebo, lixisenatide‐treated patients had significantly greater reductions in HbA1c, 2‐hour PPG, average seven‐point SMPG, and body weight. Documented symptomatic hypoglycemia was approximately two‐fold higher in patients treated with placebo than lixisenatide (12.7% vs 5.7%). GI TEAEs occurred more frequently in the lixisenatide‐ than placebo‐treated group (34% vs 9.1%). Moderate renal insufficiency (estimated glomerular filtration rate between ≥30 and <60 mL/min/1.73 m 2 ) did not negatively affect lixisenatide efficacy or safety. A greater proportion of patients treated with lixisenatide than placebo achieved composite endpoints. Conclusions Add‐on therapy with lixisenatide in non‐frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population.