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

Abstract

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 ∼ 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 ∼ 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 ∼ 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.

Trial registration: ClinicalTrials.gov NCT00528918.

Figures

Figure 1

A: Time course of mean daily blood glucose concentrations (premeal and bedtime blood glucose concentrations) in patients treated with glulisine (■) or regular insulin (□) in combination with glargine. Numbers on top of each bar indicate the number of subjects in each group. Data are means ± SEM. Overall ANOVA, P < 0.0001. B: Mean blood glucose concentrations prebreakfast (PRE-B), 2-h postbreakfast (POST-B), prelunch (PRE-L), 2-h postlunch (POST-L), predinner (PRE-D), 2-h postdinner (POST-D), at bedtime, and at 2:00 a.m. in patients treated with glulisine (●) or regular insulin (○) in combination with glargine during the entire study. Means of prelunch, predinner, and bedtime blood glucose concentrations (P < 0.0003) and 2-h postprandial blood glucose concentrations (P < 0.03), largely determined by the short-acting insulin, were significantly lower in the glulisine group than in the regular insulin group. In contrast, fasting and 2:00 a.m. blood glucose concentrations, largely determined by glargine, were comparable in both groups (both P > 0.7). Data are means ± SEM.