Insulin Analogs Versus Human Insulin in the Treatment of Patients With Diabetic Ketoacidosis: A randomized controlled trial

• Type of Material: Article
• Authors: Guillermo Umpierrez, Emory University; Sidney Jones, University of Minnesota; Dawn Smiley, Emory University; Patrick Mulligan, Emory University; Trevor Keyler, University of Minnesota; Angel Temponi, Emory University; Crispin Semakula, University of Minnesota; Denise Umpierrez, Emory University; Limin Peng, Emory University; Miguel Ceron, Emory University; Gonzalo Robalino, Emory University
• Language: English
• Date: 2009-04-14
• Publisher: American Diabetes Association
• Publication Version: Final Published Version
• Copyright Statement: © 2009 by the American Diabetes Association.
• License: Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported
• Final Published Version (URL): http://care.diabetesjournals.org/content/32/7/1164
• Title of Journal or Parent Work: Diabetes Care
• ISSN: 0149-5992
• Volume: 32
• Issue: 7
• Start Page: 1164
• End Page: 1169
• Grant/Funding Information: G.E.U. is supported by research grants from the American Diabetes Association (7-03-CR-35) and the National Institutes of Health (U01 DK074556-01 and Clinical and Translational Science Award [General Clinical Research Center] M01 RR-00039).; This investigator-initiated study was supported by an unrestricted grant from sanofi-aventis (Bridgewater, NJ).
• Research Categories: Health Sciences, Public Health; Health Sciences, General

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.