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Johannes Plank, MD; Andrea Siebenhofer, MD; Andrea Berghold, MsC, PhD; Klaus Jeitler, MD; Karl Horvath, MD; Peter Mrak, MD; Thomas R. Pieber, MD

Arch Intern Med. 2005;165:1337-1344.

Background  This article compares the effect of treatment with short-acting insulin (SAI) analogues vs regular insulin on glycemic control, hypoglycemic episodes, quality of life, and diabetes-specific complications.

Methods  Electronic searches (Cochrane Library, MEDLINE, and EMBASE) and additional searching (pharmaceutical companies, experts, approval agencies, abstracts of diabetology meetings) were performed. Two reviewers independently screened randomized controlled trials to determine inclusion.

Results  Forty-two randomized controlled trials that assessed the effect of SAI analogues vs regular insulin in 7933 patients with type 1 diabetes mellitus, type 2 diabetes mellitus, and gestational diabetes mellitus were identified. The weighted mean difference between hemoglobin A_1c values obtained using SAI analogues and regular insulin was –0.12% (95% confidence interval [CI], –0.17% to –0.07%) for adult patients with type 1 diabetes mellitus and –0.02% (95% CI, –0.10% to 0.07%) for patients with type 2 diabetes mellitus. The standardized mean difference for overall hypoglycemia (episodes per patient per month) was –0.05 (95% CI, –0.22 to 0.11) and –0.04 (95% CI, –0.12 to 0.04) comparing SAI analogues with regular insulin in adult patients with type 1 and type 2 diabetes mellitus, respectively. No differences between treatments were observed in children with type 1 diabetes, pregnant women with type 1 diabetes mellitus, and women with gestational diabetes. Concerning quality of life, improvement was observed only in open-label studies in patients with type 1 diabetes mellitus. No differences were seen in a double-blinded study of patients with type 1 or in the studies of patients with type 2 diabetes mellitus.

Conclusion  Our analysis suggests only a minor benefit to hemoglobin A_1c values in adult patients with type 1 diabetes mellitus but no benefit in the remaining population with type 2 or gestational diabetes from SAI analogue treatment.

Author Affiliations: Department of Internal Medicine, Division of Diabetes and Metabolism (Drs Plank, Siebenhofer, Jeitler, Horvath, and Pieber), and Institute for Medical Informatics, Statistics and Documentation (Dr Berghold), Medical University, Graz, Department of Internal Medicine, Landeskrankenhaus, Hörgas (Dr Mrak), and Joanneum Research, Institute of Medical Technologies and Health Management, Graz (Drs Jeitler and Pieber), Austria.

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