Endocrinology

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Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo
Trials, 09/09/09

Horie Y et al. – The study has also been designed to evaluate the safety and efficacy of linagliptin by comparing it with another antidiabetic, voglibose, over a 26–week treatment period. Four treatment groups have been established for these comparisons. A phase IIb/III combined study design has been utilized for this purpose and the approach for calculating sample size is described.

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