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. 2014 Dec 19;4(12):e005325. doi: 10.1136/bmjopen-2014-005325

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Sequential analysis of risk ratios (random effects) in randomised controlled trials on lixisenatide versus placebo or active interventions for patients with type 2 diabetes and elevated alanine aminotransferase (ALT) at baseline. The analysis was performed with α 5%, power 80%, model-based diversity correction 12%, relative risk reduction 8% and control group incidence rate 51%. The outcome measure is normalisation of ALT. The analysis shows that lixisenatide has a beneficial effect on normalisation of ALT when assessed using the traditional 5% level of significance (the horizontal line), but not after adjusting for cumulative assessment (the trial monitoring boundary).