Why are hypoglycaemia rates much higher than reported previously?
Pioglitazone was force dose-titrated in the first 3 months of the study in a double-blind manner. During any titration of glucose-lowering therapies, increased surveillance for hypoglycaemia is standard practice. The reported events happened primarily in the first 6 months of treatment initiation. This is consistent with aggressive treatment by investigators to reach IDF glycaemic targets.
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