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Published online August 3, 2007
Diabetes Care 30:2506-2507, 2007
DOI: 10.2337/dc06-2114
© 2007 by the American Diabetes Association
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Clinical Care/Education/Nutrition/Psychosocial Research
Original Article

Dose-Response Relationship of Insulin Glulisine in Subjects With Type 1 Diabetes

Reinhard H.A. Becker, MD1, Annke D. Frick, PHD1, Leszek Nosek, MD2, Lutz Heinemann, PHD2 and Klaus Rave, MD2

1 sanofi-aventis, Frankfurt/Main, Germany
2 Profil Institute for Metabolic Research, Neuss, Germany

Address correspondence and reprint requests to Reinhard Becker, MD, sanofi-aventis, Building H831, Room C 0441, Frankfurt, Germany. E-mail: reinhard.becker@sanofi-aventis.com

Abbreviations: AUC, area under the curve • GIR, glucose infusion rate • PE, point estimate • RHI, regular human insulin

The first 20% of the full text of this article appears below.


   INTRODUCTION
 
Rapidly absorbed and acting insulin analogs are increasingly being used to improve postprandial metabolic control (1), which may help in reducing cardiovascular-related and all-cause mortality in patients who already have good metabolic control (A1C <8%) (2). Insulin glulisine is a new insulin analog (3) and, unlike other insulin analog products, is formulated without added zinc to achieve sufficient physical shelf life (4). This unique formulation allows for the immediate availability of monomeric and dimeric insulin glulisine molecules after injection, which is key for rapid absorption into the blood stream from subcutaneous tissue (5). Pharmacokinetic, pharmacodynamic, and safety studies of insulin glulisine in healthy volunteers and patients with diabetes have shown that subcutaneous injection of insulin glulisine more closely mimics physiologic postprandial insulin action than regular human insulin (RHI) (6). Indeed, superior metabolic control was achieved with insulin glulisine compared with RHI in subjects with type 1 diabetes on effectively titrated basal insulin regimens (7). However, despite the increasing use of rapid-acting insulin analogs, surprisingly little is known about dose escalation on systemic insulin concentrations and metabolic activity in subjects with diabetes. This study was conducted to investigate the dose-exposure and dose-response relationships of insulin glulisine compared with RHI in subjects with type 1 diabetes.


   RESEARCH DESIGN AND METHODS—
 
In a single-center, randomized, euglycemic, glucose clamp trial, 18 male patients with type 1 diabetes were included in the study (aged 35.0 ± 9.2 years, BMI 24.5 ± 2.7 . . . [Full Text of this Article]


   RESULTS—
 

   CONCLUSIONS—
 

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