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First, it was designed to answer two primary outcomes: glycemic control and treatment failure as a result of either poor glycemic control or adverse effects. We chose to add treatment failure as a primary outcome, as opposed to previous studies, because we believed that this outcome better answers which drug is superior, which particularly holds true in the case of glycemic control eventually being achieved in both groups with insulin with which treatment failure is rare.
Analysis of only the patients with good glycemic control after oral treatment is also problematic because of selection bias of the successful group of each treatment, in which smaller differences between glucose levels are expected, leading to the study being underpowered. Second, this study examined the usefulness of the second oral hypoglycemic agent as second-line therapy and insulin only as a third-line therapy. To our knowledge, this study is the first to examine this objective.
We hypothesized that because the two medications act with different mechanisms 1, 2, one would succeed where the other failed to achieve glycemic control and particularly if the medication was discontinued because of adverse effects.
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