The effect of adjusting for baseline hypoglycemia when analyzing hypoglycemia data: a systematic analysis of 15 diabetes clinical trials

Baseline hypoglycemia rates are generally not collected or included as a covariate in statistical models used for analyzing hypoglycemia data. The objective of the present study was to examine the effect of adjusting for baseline hypoglycemia on estimation efficiency and statistical power. A post hoc analysis of data from 15 insulin trials, including patients with type 1 diabetes mellitus (T1DM) (n=210), previously insulin-treated type 2 diabetes mellitus (T2DM) (n=1,511), or T2DM and previously insulin-naive (n=1,075). Hypoglycemic episodes were analyzed with a negative binomial regression model. Baseline nocturnal hypoglycemia rate was significantly correlated with post-baseline nocturnal hypoglycemia rate in previously insulin-treated patients with T1DM and T2DM (correlation range, 0.37-0.63; P