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Exp Clin Endocrinol Diabetes 1996; 104(1): 25-30
DOI: 10.1055/s-0029-1211418
Original

© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycemic episodes

A. Pfützner1 , 2 , E. Küstner1 , T. Forst1 , B. Schulze-Schleppinghoff3 , M. E. Trautmann2 , M. Haslbeck4 , H. Schatz5 , J. Beyer1 on behalf of the German Insulin Lispro/IDDM study group *
  • 1III. Med. Klinik, Innere Medizin & Endokrinologie, Langenbeckstr. 1, D-55101 Mainz
  • 2Lilly Deutschland GmbH, Saalburgstr. 153, D-61350 Bad Homburg
  • 3Diabeteszentrum, Elisabethkrankenhaus, Moltkestr. 61, D-45138 Essen
  • 4Institut für Diabetesforschung, III. Medizinische Abteilung, Krankenhaus München Schwabing, Kölner Platz 1, D-80804 München
  • 5Med. Klinik und Poliklinik, Berufsgenoss. Kliniken Bergmannsheil, Universitätsklinik, Gilsingstr. 14, D-44789 Bochum
  • * Prof. J. Beyer, III. Medizinische Klinik, Innere Medizin und Endokrinologie, Mainz
    Prof. R.D. Fussgänger, Zentrum für Innere Medizin, Universitätsklinik, Ulm.
    Prof. K. Federlin, Med. Klinik III und Poliklinik der Universität, Giessen.
    Prof. F.A. Gries, Diabetesforschungsinstitut der Universität, Düsseldorf
    Prof. M.Haslbeck, Institut für Diabetesforschung, Krankenhaus München-Schwabing
    Dr. H.U. Jastram, Diabeteszentrum an der Kinderklinik, Kaiserslautern
    PD Dr. I. Koop, Universitätsklinik Lahnberge, Marburg
    Prof. R. Landgraf, Medizinische Klinik Innenstadt, Stadtkrankenhaus, München
    PD Dr. C. Rosak, Krankenhaus Sachsenhausen, Stoffwechselabteilung, Frankfurt
    Prof. H. Schatz, Prof. E. Schifferdecker, Med. Klinik u. Poliklinik der Universitätsklinken Bergmannsheil, Bochum
    Dr. B. Schulze-Schleppinghoff, Diabeteszentrum, Elisabeth-Krankenhaus, Essen
    Prof. F.J. Seif, Medizinische Klinik und Poliklinik IV der Universität, Tübingen
    Prof. F. Stoeckamann, Med. Universitätsklinik, Göttingen
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Publication History

Publication Date:
15 July 2009 (online)

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Summary

In a randomized, open-label, controlled cross-over trial, 107 patients with type 1 diabetes were treated with either regular human insulin or insulin lispro, a rapid-acting insulin analogue. After a lead-in period of 2 to 4 weeks, the patients were randomized to receive intensified insulin treatment with one of the insulins. NPH-human insulin was used for basal substitution in both groups. The crossover took place after 3 months of treatment. Efficacy and safety of the drugs were established by the assessment of hemoglobin A1C, pretest blood glucose, 1 and 2-hour postprandial glucose excursions, number of hypoglycemic episodes, daily insulin doses, body weight, insulin antibodies, and the number and severity of adverse events. A questionnaire comprised of four primary domains was used to measure some quality of life aspects of the patients.

Both treatment regimens were well tolerated. While no differences were seen in the hemoglobin A1C values, there was a trend for a decrease in the pretest blood glucose levels and significant decreases of the 1 and 2-hour postprandial glucose excursions in the patients treated with insulin lispro. The number of hypoglycemic episodes was also significantly lower in the insulin lispro treatment period. The evaluation of the quality of life questionnaire revealed an improvement in the patients treatment satisfaction for the insulin lispro group. During treatment with insulin lispro, the basal insulin doses increased slightly. However, the total daily insulin doses decreased to a greater extent with insulin lispro as compared to regular human insulin. Human insulin-specific antibody binding values at endpoint were not different for the two treatments

In conclusion, intensive insulin treatment with insulin lispro therapy results in improved postprandial glycemic control and HbA1c levels at least equal to the treatment with regular human insulin but with less hypoglycemia and more treatment satisfaction for the patient.

Key words

Insulin lispro - Type 1 diabetes - Hypoglycemia