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Ann Pharmacother. 2009 Apr;43(4):658-68. doi: 10.1345/aph.1E662. Epub 2009 Mar 31.

Insulin glulisine: an evaluation of its pharmacodynamic properties and clinical application.

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1
Harrison School of Pharmacy, Auburn University, AL 36849, USA.

Abstract

OBJECTIVE:

To evaluate the pharmacodynamic properties, efficacy, safety, and clinical application of insulin glulisine, a rapid-acting insulin analog, in the treatment of diabetes mellitus in ambulatory and hospitalized patients.

DATA SOURCES:

Searches were performed with the headings glulisine, insulin analog, [LysB3, GluB29] insulin, insulin glulisine, rDNA insulin, rapid-acting insulin, SoloStar, safety, efficacy, pharmacodynamics, and cost analysis within MEDLINE and PubMed, American Diabetes Association (ADA), the Food and Drug Administration (FDA), and Sanofi-aventis Pharmaceuticals (1990-August 2008).

STUDY SELECTION AND DATA EXTRACTION:

Phase 1, Phase 2, Phase 3, and postmarketing trials examining the efficacy and safety of glulisine in type 1 or type 2 diabetes were reviewed. Studies published as abstracts and the manufacturer's product information supplemented data absent from clinical trials.

DATA SYNTHESIS:

Insulin glulisine is a rapid-acting insulin with relative equivalence in efficacy and safety to other short- and rapid-acting insulins. Glulisine's onset of action of 20 minutes and 4-hour duration of action allow for bolus administration 15-20 minutes prior to or up to 20 minutes after meals. Clinical trials have demonstrated the safety and efficacy in adults with type 1 or type 2 diabetes. Several studies indicated a statistically significant decrease of hemoglobin A1C (A1C) with glulisine compared with regular insulin (0.10 decrease); however, no difference in A1C control was found compared with insulin aspart or lispro. Significant adverse effects appear to be limited to localized and systemic allergic reactions and hypoglycemia.

CONCLUSIONS:

Insulin glulisine is a safe and effective rapid-acting insulin analog for the treatment of adults with diabetes. Clinical benefit over other short- and rapid-acting insulin products is not established. Addition of insulin glulisine to a formulary should be based on institution-specific availability and cost differences between glulisine, lispro, and aspart in the absence of superiority of clinical efficacy or safety and data beyond 26 weeks.

PMID:
19336657
DOI:
10.1345/aph.1E662
[Indexed for MEDLINE]

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