Peking University People's Hospital, 11 Xizhimen Nan Dajie, Xicheng District, Beijing, China.
Cardiovasc Diabetol. 2013 Aug 19;12:118. doi: 10.1186/1475-2840-12-118.
Limitations of the currently recommended stepwise treatment pathway for type 2 diabetes mellitus (T2DM), especially the failure of monotherapies to maintain good glycemic control, have prompted use of early, more aggressive combination therapies.The VISION study is designed to explore the efficacy and safety of vildagliptin as an add-on to metformin therapy compared with up-titration of metformin monotherapy in Chinese patients with T2DM.
VISION, a 24-week, phase 4, prospective, randomized, multicenter, open-label, parallel-group study, will include 3312 Chinese T2DM patients aged ≥18 years who are inadequately controlled (6.5% >HbA1c ≤9%) by metformin (750-1000 mg/day). Eligible patients will be randomized to receive either vildagliptin plus metformin or up-titration of metformin monotherapy (5:1). Patients will also be subgrouped (1:1:1:1) based on their age and body mass index (BMI): <60 years and <24 kg/m²; <60 years and ≥24 kg/m²; ≥60 years and <24 kg/m²; and ≥60 years and ≥24 kg/m².
The VISION study will test the hypothesis that early use of combination therapy with vildagliptin and metformin will provide good glycemic control and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with age and BMI.
目前推荐的 2 型糖尿病（T2DM）阶梯式治疗方案存在局限性，尤其是单一疗法无法维持良好的血糖控制，这促使人们更早地使用更积极的联合治疗方案。VISION 研究旨在探索维格列汀作为二甲双胍治疗的附加疗法与二甲双胍单药剂量递增相比，在治疗中国 T2DM 患者中的疗效和安全性。
这是一项为期 24 周的 4 期、前瞻性、随机、多中心、开放性、平行组研究，将纳入 3312 例年龄≥18 岁、二甲双胍（750-1000mg/天）控制不佳（6.5%＜HbA1c≤9%）的中国 T2DM 患者。符合条件的患者将被随机分为维格列汀联合二甲双胍组或二甲双胍单药剂量递增组（5:1）。根据年龄和体重指数（BMI）将患者进一步分组（1:1:1:1）：＜60 岁且＜24kg/m²；＜60 岁且≥24kg/m²；≥60 岁且＜24kg/m²；≥60 岁且≥24kg/m²。
VISION 研究将检验以下假设：早期使用维格列汀和二甲双胍联合治疗方案将提供良好的血糖控制，并且比二甲双胍单药剂量递增更耐受。该研究还将这些益处与年龄和 BMI 相关联。
