A pre-specified statistical analysis plan for the VERIFY study: Vildagliptin efficacy in combination with metformin for early treatment of T2DM.

David R MatthewsPäivi M PaldániusMichael StumvollJackie HanGiovanni BaderYannTong ChiangPieter ProotStephano Del Prato

Published in: Diabetes, obesity & metabolism (2019)

According to optimal trial practice, the details of the statistical analysis and data-handling plan prior to locking the database are reported here. The SAP accords with high-quality standards of internal validity to minimize analysis bias and will enhance the utility of the reported results for improved outcomes in the management of T2DM.

Keyphrases

primary care
healthcare
glycemic control
study protocol
phase iii
electronic health record
randomized controlled trial
type diabetes
emergency department
data analysis
adipose tissue
metabolic syndrome
insulin resistance
skeletal muscle
replacement therapy