Results:

Mean age was approximately 64 years, 34% were women; nearly 60% had coronary disease or stroke; approximately 90% had diabetes, and mean baseline glycated hemoglobin (HgA_1c) was approximately 6.5%. During follow-up, approximately 25% of participants had at least one episode of hypoglycemia. Of these, 74.3% occurred in the glargine group and 25.7% in the standard group. Of the 472 participants with at least one episode of severe hypoglycemia, 76.1% occurred in the glargine group and 23.9% in the standard group with an estimated annual incidence of 0.9% and 0.3%, respectively. Nonsevere hypoglycemia was not associated with any outcome following adjustment. Conversely, severe hypoglycemia was associated with a significantly greater risk for the primary outcome (hazard ratio [HR], 1.58), mortality (HR, 1.74), CV death (HR, 1.71), and arrhythmic death (HR, 1.77). Similar findings were noted for severe nocturnal hypoglycemia for the primary outcome and mortality. The severe hypoglycemia hazard for all four outcomes was higher with standard care than with insulin glargine. For both types of episodes, affected participants were more likely to be men than women, had a higher baseline fasting plasma glucose and HbA_1c, and were more often treated with a sulfonylurea.