Hypoglycemia Evidence about the magnitude and statistical significance of the risk of hypoglycemia and its complications is inconsistent across clinical trials. Furthermore, the risk of severe hypoglycemia appears to differ between patients with type 1 and type 2 diabetes, being greater in the former and therefore not reviewed here. Some trials involving patients with type 2 disease reported an increased risk for minor hypoglycemic episodes. The incidence of any hypoglycemic episode, including minor events, was higher among intensively treated patients than among controls. A recent cohort study of 8668 patients with type 2 diabetes provides data from community practice at a large health maintenance organization.
Weight gain Several trials have reported an association between intensive treatment and weight gain.
At five years, patients in the intensive treatment group had gained an average of 4.6 kg more than those receiving conventional therapy. There is no evidence that this amount of weight gain in an obese individual significantly impacts on outcomes. In many cases these inconveniences, discomforts, and costs must be borne over a number of years, often a lifetime. There are currently few reliable data on which to measure the magnitude of these problems, their relative importance to patients, or the degree to which they are offset by the benefits of treatment.