Swansea University, Diabetes Research Group Cymru, College of Medicine, Swansea, UK.
Sanofi, Frankfurt, Germany.
Diabetes Obes Metab. 2019 Feb;21(2):321-329. doi: 10.1111/dom.13607.
To identify factors associated with achievement of glycated haemoglobin A1c (HbA1c) target at 24 weeks after commencing basal insulin therapy in individuals with type 2 diabetes mellitus (T2DM).
Post-hoc pooled analysis of 16 randomized, treat-to-target trials involving individuals with T2DM inadequately controlled with oral anti-hyperglycaemic drugs (n = 3415) initiated on once-daily insulin glargine 100 U/mL (Gla-100). Clinical outcomes were assessed by HbA1c response at 24 weeks and individuals were classified as "good responders" with HbA1c <7.0% (<53 mmol/mol) or as "poor responders" with HbA1c ≥7.0% (≥53 mmol/mol). Univariable and multivariable stepwise logistic regression analyses were performed to identify predictive factors for attaining HbA1c <7.0%.
Lower levels of baseline HbA1c, fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG), higher body mass index (BMI), shorter diabetes duration and male sex were associated with a good glycaemic response, but not age or baseline C-peptide levels. Gla-100 dose (U/kg) was highest in the poor-responder group, which had the fewest hypoglycaemia episodes. Univariable analysis for achievement of HbA1c <7.0% confirmed these observations. Multivariable analysis retained baseline HbA1c, body weight, BMI, sex, 2-hours PPG and diabetes duration as predictors of a good response. Continued use of sulfonylureas, hypoglycaemia and change in body weight were indicative of poor response.
Baseline HbA1c was the strongest determinant for achieving target HbA1c <7.0% by supplementary Gla-100 therapy, while sex and BMI were also useful indicators. However, age and C-peptide levels at baseline did not predict glycaemic response to the introduction of basal insulin.
确定在 2 型糖尿病(T2DM)患者开始每日一次基础胰岛素甘精胰岛素 100U/mL(Gla-100)治疗 24 周后,与糖化血红蛋白 A1c(HbA1c)目标达成相关的因素。
对 16 项随机、靶向治疗试验的事后汇总分析,共纳入 3415 例口服降糖药物控制不佳的 T2DM 患者,起始给予每日一次甘精胰岛素 100U/mL。通过 24 周时的 HbA1c 反应评估临床结局,将 HbA1c<7.0%(<53mmol/mol)的患者归为“良好反应者”,将 HbA1c≥7.0%(≥53mmol/mol)的患者归为“不良反应者”。进行单变量和多变量逐步逻辑回归分析,以确定达到 HbA1c<7.0%的预测因素。
基线 HbA1c、空腹血糖(FPG)和餐后血糖(PPG)水平较低、体重指数(BMI)较高、糖尿病病程较短和男性与良好的血糖反应相关,但与年龄或基线 C 肽水平无关。不良反应者组的 Gla-100 剂量(U/kg)最高,低血糖发作次数最少。单变量分析证实了达到 HbA1c<7.0%的这一观察结果。多变量分析保留了基线 HbA1c、体重、BMI、性别、2 小时 PPG 和糖尿病病程作为良好反应的预测因素。继续使用磺脲类药物、低血糖和体重变化提示不良反应。
基线 HbA1c 是补充 Gla-100 治疗达到目标 HbA1c<7.0%的最强决定因素,而性别和 BMI 也是有用的指标。然而,基线时的年龄和 C 肽水平并不能预测基础胰岛素引入后的血糖反应。