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Table 2 Primary, secondary, and exploratory objectives of the VISION study

From: 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. Primary objective:
• To demonstrate that the change from baseline in HbA1c levels after 24 weeks of treatment with vildagliptin 50 mg bid as add-on therapy to metformin 500 mg bid is non-inferior to high-dose metformin
2. Secondary objectives:
• To demonstrate in predefined patient subgroups [based on body mass index (BMI <24 and ≥24 kg/m2) and age (<60 and ≥60 years)] that vildagliptin add-on therapy to metformin is non-inferior to high-dose metformin in the change from baseline in HbA1c levels
• To determine the percentages of patients achieving the target HbA1c level of ≤6.5% in the two treatment arms of the overall population and in the predefined subgroups
• To determine the percentages of patients achieving the target HbA1c level of ≤6.5% in the two treatment arms of the overall population and in the predefined subgroups
• To determine the mean change from baseline to 24 weeks in fasting plasma glucose in the overall population and in the predefined subgroups
• To determine the mean change from baseline to 24 weeks in 2-hour postprandial glucose in a subsample of 464 patients with type 2 diabetes mellitus
• Safety analysis
3. Exploratory objectives:
• To determine the mean change from baseline to 24 weeks in body weight and lipid parameters in the overall population and in the predefined subgroups
• To determine the change from baseline to 24 weeks in β-cell function in a subsample of 464 patients with type 2 diabetes mellitus
  1. BMI: body mass index; HbA1c: glycated hemoglobin.