Care Group Treant, Location Bethesda, Internal Medicine, Hoogeveen, The Netherlands.
MUMC, Internal Medicine, Maastricht, The Netherlands.
Diabetes Obes Metab. 2018 Mar;20(3):730-733. doi: 10.1111/dom.13123. Epub 2017 Oct 27.
In this trial, 390 insulin-treated patients with type 2 diabetes were randomized to either placebo or metformin. Fasting levels of glucose, insulin and C peptide were determined at baseline, after 4 months and yearly thereafter for 4 years to assess fasting estimates of beta cell function. The primary endpoint was the fasting C peptide-to-glucose ratio (FCPGR) and secondary measures were the disposition index (DI) and the fasting C peptide (FCP). We analysed the results with a general linear mixed model. Baseline FCPGR was 5.27 (95% CI, 4.83 - 5.71). Compared to placebo, FCPGR increased in the metformin group with 1.48 (95% CI, 1.09 - 1.87, P < 0.001). The DI showed comparable results with a treatment effect of 1.50 (95% CI, 1.17 - 1.83; P < 0.001). FCP also increased in the metformin group but did not reach statistical significance vs placebo (0.034 nmol, 95% CI, -0.005 - 0.072; P = 0.085). Treatment with metformin vs placebo, added to insulin in patients with type 2 diabetes, improves long-term estimates of beta cell function in the fasting state.
在这项试验中，390 名接受胰岛素治疗的 2 型糖尿病患者被随机分为安慰剂组或二甲双胍组。在基线、4 个月后和此后每年检测空腹血糖、胰岛素和 C 肽水平，以评估空腹β细胞功能的估计值。主要终点是空腹 C 肽与葡萄糖的比值（FCPGR），次要测量指标是处置指数（DI）和空腹 C 肽（FCP）。我们使用一般线性混合模型分析结果。基线 FCPGR 为 5.27（95%CI，4.83-5.71）。与安慰剂相比，二甲双胍组的 FCPGR 增加了 1.48（95%CI，1.09-1.87，P<0.001）。DI 显示出类似的结果，治疗效果为 1.50（95%CI，1.17-1.83；P<0.001）。二甲双胍组的 FCP 也有所增加，但与安慰剂相比无统计学意义（0.034 nmol，95%CI，-0.005-0.072；P=0.085）。与安慰剂相比，在接受胰岛素治疗的 2 型糖尿病患者中添加二甲双胍治疗可改善空腹状态下β细胞功能的长期估计值。
