Insulin Analogs Versus Human Insulin in the Treatment of Patients With Diabetic Ketoacidosis

A randomized controlled trial

  1. Guillermo E. Umpierrez, MD1,
  2. Sidney Jones, MD2,
  3. Dawn Smiley, MD1,
  4. Patrick Mulligan, BA1,
  5. Trevor Keyler2,
  6. Angel Temponi, MD1,
  7. Crispin Semakula, MD2,
  8. Denise Umpierrez, BA1,
  9. Limin Peng, PHD3,
  10. Miguel Cerón, MD1 and
  11. Gonzalo Robalino, MD1
  1. 1Department of Medicine, Emory University School of Medicine, Atlanta, Georgia;
  2. 2Department of Medicine, University of Minnesota School of Medicine, Minneapolis, Minnesota;
  3. 3Department of Medicine, Rollins School of Public Health, Emory University, Atlanta, Georgia.
  1. Corresponding author: Guillermo Umpierrez, geumpie{at}emory.edu.

Abstract

OBJECTIVE To compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

RESEARCH DESIGN AND METHODS In a controlled multicenter and open-label trial, we randomly assigned patients with DKA to receive intravenous treatment with regular or glulisine insulin until resolution of DKA. After resolution of ketoacidosis, patients treated with intravenous regular insulin were transitioned to subcutaneous NPH and regular insulin twice daily (n = 34). Patients treated with intravenous glulisine insulin were transitioned to subcutaneous glargine once daily and glulisine before meals (n = 34).

RESULTS There were no differences in the mean duration of treatment or in the amount of insulin infusion until resolution of DKA between intravenous treatment with regular and glulisine insulin. After transition to subcutaneous insulin, there were no differences in mean daily blood glucose levels, but patients treated with NPH and regular insulin had a higher rate of hypoglycemia (blood glucose <70 mg/dl). Fourteen patients (41%) treated with NPH and regular insulin had 26 episodes of hypoglycemia and 5 patients (15%) in the glargine and glulisine group had 8 episodes of hypoglycemia (P = 0.03).

CONCLUSIONS Regular and glulisine insulin are equally effective during the acute treatment of DKA. A transition to subcutaneous glargine and glulisine after resolution of DKA resulted in similar glycemic control but in a lower rate of hypoglycemia than with NPH and regular insulin. Thus, a basal bolus regimen with glargine and glulisine is safer and should be preferred over NPH and regular insulin after the resolution of DKA.

Footnotes

  • Clinical trial reg. no. NCT00596687, clinicaltrials.gov.

  • The sponsors of the study were not involved in the study design, data collection, analysis interpretation of the results, or preparation of the manuscript.

  • The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.

    • Received January 28, 2009.
    • Accepted March 23, 2009.
  • Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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