Insulin Glulisine Provides Improved Glycemic Control in Patients With Type 2 Diabetes
- George Dailey, MD1,
- Julio Rosenstock, MD2,
- Robert G. Moses, MD3 and
- Kirk Ways, MD, PHD4
- 1Scripps Clinic, La Jolla, California
- 2Dallas Diabetes and Endocrine Center, Dallas, Texas
- 3Wollongong Hospital, Wollongong, NSW, Australia
- 4Aventis 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
Abstract
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 HbA1c 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 HbA1c 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.
- ITT, intention to treat
- OAD, oral antidiabetic agent
- RHI, regular human insulin
- TEAE, treatment-emergent adverse event
Footnotes
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G.D. has received honoraria, research grants, and served as an occasional consultant for Aventis, Bristol-Myers Squibb, Merck, Novo Nordisk, Pfizer, Eli Lilly, GlaxoSmithKline, and Amylin; has served on a speakers bureau only for Merck Sante; and has been an investigator for Schering-Plough, Takeda, Kowa, ACON, Forest, and Becton-Dickinson. J.R. has served as a consultant and/or on a speakers bureau for Aventis, Pfizer, Novo Nordisk, Takeda, GlaxoSmithKline, and Johnson & Johnson; and has received research support from Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Novo Nordisk, Pfizer, Aventis, Novartis, Takeda, AstraZeneca, and Merck. K.W. holds stock in Bristol-Myers Squibb and Lilly.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted July 19, 2004.
- Received January 22, 2004.
- DIABETES CARE
