Glulisine versus human regular insulin in combination with glargine in noncritically ill hospitalized patients with type 2 diabetes: a randomized double-blind study.

摘要

OBJECTIVE: To compare the efficacy and safety of the rapid-acting insulin analog glulisine and regular insulin in hyperglycemic hospitalized patients. RESEARCH DESIGN AND METHODS: A total of 180 hospitalized patients with type 2 diabetes received either glulisine (n = 88) or regular insulin (n = 92) before each meal in combination with insulin glargine at bedtime in a randomized double-blind fashion. All previous diabetes medications were discontinued if applicable. Doses of insulin were adjusted to obtain target blood glucose concentrations of <130 mg/dl before meals and at bedtime while avoiding hypoglycemia. RESULTS: Overall mean blood glucose concentrations were approximately 8 mg/dl lower in the glulisine group than in the regular insulin group (152.6 +/- 66.6 vs. 160.4 +/- 70.8 mg/dl; P < 0.0002). This improvement was wholly due to approximately 22 mg/dl lower levels after 4 days of therapy (140 +/- 55 vs. 162 +/- 71 mg/dl; P < 0.0007); after day 4, this difference progressively increased such that mean blood glucose concentrations from day 7 onward were approximately 31 mg/dl lower in the glulisine group. The mean daily incidence of hypoglycemia was slightly but not significantly lower in the glulisine than the regular insulin group (0.10 +/- 0.02 vs. 0.14 +/- 0.03 episode/day; P > 0.35). CONCLUSIONS: In hospitalized type 2 diabetic patients, glulisine may provide better glycemic control than regular insulin, especially in those who have a prolonged length of stay.