Introduction To assess secondary metformin monotherapy (MM) failure in a real-world type 2 diabetes mellitus (T2DM) cohort. Research design and methods Using the IQVIA Electronic Medical Record (formerly GE Centricity) database, adults with T2DM who initiated MM between January 1, 2012 and June 30, 2016 and achieved glycemic control (hemoglobin A1c (HbA1c) <7% (53 mmol/mol); index date) were analyzed. Secondary MM failure was defined in two ways: loss of glycemic control (HbA1c ≥7% (53 mmol/mol)) and treatment change (addition or switch of antihyperglycemic agent). Multivariable logistic regression models assessed the association between secondary MM failure and sociodemographic and clinical factors. Results The analysis included 4775 patients initiating MM. 32.9% and 19.2% experienced secondary MM failure at 24 months measured as loss of glycemic control and treatment change, respectively. Multivariable logistic regression found that women (OR=1.3, 95% CI 1.1 to 1.5) compared with men, lower Charlson Comorbidity Index (CCI) (OR=0.89, 95% CI 0.86 to 0.93), and lower baseline HbA1c (OR=0.93, 95% CI 0.88 to 0.98) were associated with increased likelihood of loss of glycemic control. Lower CCI was associated with increased likelihood of treatment change (OR=0.78, 95% CI 0.75 to 0.82). Conclusions The observed frequency of secondary MM failure underscores the importance of the American Diabetes Association’s recommendation for glycemic monitoring of at least every 6 months so that timely therapeutic adjustments can be made. All data relevant to the study are included in the article or uploaded as supplementary information. Merck licensed the EMR data used in this study from IQVIA. Under its agreement with IQVIA, Merck does not have the permission to release the data to or share the data with any third party without explicit contractual consent between the third party and IQVIA. The study protocol contains the specifications of the database and details of patient selection. The study protocol is available upon request.

中文翻译：

---

2 型糖尿病患者继发性二甲双胍单药治疗失败

简介 评估真实世界 2 型糖尿病 (T2DM) 队列中继发性二甲双胍单药治疗 (MM) 的失败。研究设计和方法 使用 IQVIA 电子病历（以前称为 GE Centricity）数据库，在 2012 年 1 月 1 日至 2016 年 6 月 30 日期间开始 MM 并实现血糖控制（血红蛋白 A1c (HbA1c) <7% (53 mmol/ mol)；索引日期)进行分析。继发性 MM 失败以两种方式定义：血糖控制丧失（HbA1c ≥ 7% (53 mmol/mol)）和治疗改变（添加或更换抗高血糖药）。多变量逻辑回归模型评估了继发性 MM 失败与社会人口学和临床因素之间的关联。结果 分析包括 4775 名开始 MM 的患者。32.9% 和 19。2% 的患者在 24 个月时出现继发性 MM 失败，分别以血糖控制丧失和治疗改变来衡量。多变量逻辑回归发现，女性（OR=1.3，95% CI 1.1 至 1.5）与男性相比，Charlson 合并症指数 (CCI) 较低（OR=0.89，95% CI 0.86 至 0.93），基线 HbA1c 较低（OR=0.93） , 95% CI 0.88 至 0.98) 与失去血糖控制的可能性增加有关。较低的 CCI 与治疗改变的可能性增加有关（OR = 0.78，95% CI 0.75 至 0.82）。结论 观察到的继发性 MM 失败的频率强调了美国糖尿病协会建议至少每 6 个月监测一次血糖的重要性，以便及时调整治疗。与研究相关的所有数据都包含在文章中或作为补充信息上传。默克从 IQVIA 获得了本研究中使用的 EMR 数据的许可。根据其与 IQVIA 的协议，未经第三方与 IQVIA 之间的明确合同同意，默克无权向任何第三方发布或共享数据。研究方案包含数据库的规格和患者选择的详细信息。研究方案可应要求提供。研究方案包含数据库的规格和患者选择的详细信息。研究方案可应要求提供。研究方案包含数据库的规格和患者选择的详细信息。研究方案可应要求提供。