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Insulin Glulisine Provides Improved Glycemic Control in Patients With Type 2 Diabetes

¹ Scripps Clinic, La Jolla, California
² Dallas Diabetes and Endocrine Center, Dallas, Texas
³ Wollongong Hospital, Wollongong, NSW, Australia
⁴ Aventis Pharma, Bridgewater, New Jersey

Address correspondence and reprint requests to George Dailey, MD, Scripps Clinic, 10666 North Torrey Pines Rd., La Jolla, CA 92037. E-mail: dailey.george{at}scrippshealth.org

OBJECTIVE—Insulin glulisine is a novel analog of human insulin designed for use as a rapid-acting insulin. This study compared the safety and efficacy of glulisine with regular human insulin (RHI) in combination with NPH insulin.

RESEARCH DESIGN AND METHODS—In total, 876 relatively well-controlled patients with type 2 diabetes (mean HbA_1c 7.55%) were randomized and treated with glulisine/NPH (n = 435) or RHI/NPH (n = 441) for up to 26 weeks in this randomized, multicenter, multinational, open-label, parallel-group study. Subjects were allowed to continue the same dose of prestudy regimens of oral antidiabetic agent (OAD) therapy (unless hypoglycemia necessitated a dose change).

RESULTS—A slightly greater reduction from baseline to end point of HbA_1c was seen in the glulisine group versus RHI (–0.46 vs. –0.30% with RHI; P = 0.0029). Also, at end point, lower postbreakfast (156 vs. 162 mg/dl [8.66 vs. 9.02 mmol/l]; P < 0.05) and postdinner (154 vs. 163 mg/dl [8.54 vs. 9.05 mmol/l]; P < 0.05) blood glucose levels were noted. Symptomatic hypoglycemia (overall, nocturnal, and severe) and weight gain were comparable between the two treatment groups. There were no between-group differences in baseline-to-end point changes in insulin dose.

CONCLUSIONS—Twice-daily glulisine associated with NPH can provide small improvements in glycemic control compared with RHI in patients with type 2 diabetes who are already relatively well controlled on insulin alone or insulin plus OADs. The clinical relevance of such a difference remains to be established.

Abbreviations: ITT, intention to treat • OAD, oral antidiabetic agent • RHI, regular human insulin • TEAE, treatment-emergent adverse event

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