The aim of the study was to evaluate remission of type 2 diabetes following a short-term intervention with insulin glargine, sitagliptin/metformin, and lifestyle approaches.

In this open multicenter trial, 102 patients with type 2 diabetes were randomized to 1) a 12-week intervention with sitagliptin/metformin, insulin glargine and lifestyle therapy, or 2) control group. Participants with HbA_1c <7.3% (<56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for evidence of relapse over 52 weeks. Diabetes relapse criteria included HbA_1c ≥6.5% (≥48 mmol/mol), ≥50% of capillary glucose readings >10 mmol/L over 1 week, and reinitiation of diabetes medications with or without abnormal fasting plasma glucose (FPG) or 2-h plasma glucose on an oral glucose tolerance test (OGTT). Time-to-relapse analysis was conducted to compare the treatment groups with (primary analysis) and without (supplementary analysis) FPG/OGTT relapse criteria.

With the FPG/OGTT relapse criteria included, the hazard ratio (HR) of relapse was 0.72 (95% CI 0.47–1.10) in the intervention group compared with the control group (primary analysis), and the number of participants remaining in remission was not significantly different between treatment groups at 24, 36, 48, and 64 weeks. In the supplementary analyses without these criteria, HR of relapse was 0.60 (95% CI 0.39–0.95), and the number of participants remaining in remission was significantly higher (26 vs. 10%) in the intervention group at 36 weeks.

Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components.

该研究的目的是评估使用甘精胰岛素、西他列汀/二甲双胍和生活方式方法进行短期干预后 2 型糖尿病的缓解情况。

在这项开放的多中心试验中，102 名 2 型糖尿病患者被随机分配到1 ) 1) 12 周的西他列汀/二甲双胍干预、甘精胰岛素和生活方式治疗，或2 ) 对照组。_{12 周时HbA1c} <7.3%（<56 毫摩尔/摩尔）的参与者被要求停止糖尿病药物治疗，并在 52 周内接受随访以寻找复发证据。糖尿病复发标准包括 HbA _1c≥6.5% (≥48 mmol/mol)，≥50% 的毛细血管葡萄糖读数在 1 周内 >10 mmol/L，并且在有或没有异常空腹血糖 (FPG) 或 2 小时血浆葡萄糖的情况下重新开始糖尿病药物治疗口服葡萄糖耐量试验（OGTT）。进行了复发时间分析，以比较治疗组（主要分析）和没有（补充分析）FPG/OGTT 复发标准。

纳入 FPG/OGTT 复发标准后，与对照组相比，干预组的复发风险比 (HR) 为 0.72（95% CI 0.47–1.10）（主要分析），并且处于缓解状态的参与者人数为在 24、36、48 和 64 周时，治疗组之间没有显着差异。在没有这些标准的补充分析中，复发的 HR 为 0.60（95% CI 0.39–0.95），并且干预组在 36 周时保持缓解状态的参与者人数显着增加（26 对 10%）。

尽管我们的主要结果没有统计学意义，但经过测试的方法值得进一步研究，进一步优化其组成部分。