Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study
1 Peking University People’s Hospital, 11 Xizhimen Nan Dajie, Xicheng District, Beijing, China
2 Chinese PLA General Hospital, No. 28 Fuxing Street, Beijing 100853, China
3 Sir Run Run Shaw Hospital, Zhejiang University Medical College, Hangzhou, China
4 The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China
5 The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
6 Shanghai First People's Hospital, Shanghai, China
7 West China Hospital, Sichuan University, Chengdu, China
8 Peking University First Hospital, Beijing, China
9 Henan Provincial People's Hospital, Zhengzhou, China
10 Beijing Novartis Pharma Co. Ltd, Beijing, China
Cardiovascular Diabetology 2013, 12:118 doi:10.1186/1475-2840-12-118Published: 19 August 2013
Background and aim
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.