Insulin lispro is a human insulin analog that dissociates more rapidly than human regular insulin after subcutaneous injection, resulting in higher insulin levels at an earlier point in time and a shorter duration of action. The aim of the study was to evaluate if this pharmacokinetic difference would translate into better postprandial and overall control in 30 IDDM patients (age, 35.1 ± 1.5 years; male-female ratio, 17:13; BMI, 24.8 ± 0.5 kg/m2; HbA1c, 8.03 ± 0.13% at baseline) treated with continuous subcutaneous insulin infusion (CSII; Disetronic H-TRON V100) in a double-blind crossover clinical study. Patients were randomized to insulin lispro or human regular insulin for 3 months before crossing over to the other insulin for another 3 months. All meal boluses were given immediately before breakfast, lunch, and supper. An eight-point blood glucose profile was measured once weekly, and HbA1c levels were measured monthly. At the end of the 3-month treatment period, HbA1c levels were significantly lower with insulin lispro, compared with human regular insulin: 7.66 ± 0.13 vs. 8.00 ± 0.16% (P = 0.0041). While preprandial, bedtime, and 2:00 A.M. values for blood glucose were not significantly different, 1-h postprandial blood glucose was significantly improved after breakfast, lunch, and dinner with insulin lispro, compared with human regular insulin: 8.35 vs. 9.79 mmol/l (P = 0.006), 7.58 vs. 8.74 mmol/l (P = 0.049), and 7.85 vs. 9.01 mmol/l (P = 0.03). The incidence of hypoglycemia per 30 days (blood glucose levels, <3.0 mmol/l) was 8.4 ± 1.3 before randomization, decreasing to 6.0 ± 0.9 for insulin lispro and to 7.6 ± 1.3 for regular insulin during the last month of the study. Two patients in each group reported insulin precipitation. We conclude that insulin lispro improves glycemic control in CSII without increasing the risk of hypoglycemia.
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Original Articles|
March 01 1997
Insulin Lispro in CSII: Results of a Double-Blind Crossover Study
Bernard Zinman;
Bernard Zinman
Samuel Lunenfeld Research Institute, Mt. Sinai Hospital, University of Toronto
Toronto, Ontario
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Hugh Tildesley;
Hugh Tildesley
University of British Columbia
British Columbia
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Jean-Louis Chiasson;
Jean-Louis Chiasson
Centre de Recherche Hôtel-Dieu de Montréal
Montréal, Québec
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Elaine Tsui;
Elaine Tsui
Samuel Lunenfeld Research Institute, Mt. Sinai Hospital, University of Toronto
Toronto, Ontario
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Thomas Strack
Thomas Strack
Eli Lilly Canada
Toronto, Ontario, Canada
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Address correspondence and reprint requests to Dr. R.A. Rizza, Endocrine Research Unit, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905.
1
CSII, continuous subcutaneous insulin infusion; DCCT, Diabetes Control and Complications Trial; FFA, free fatty acid; PEG, polyethylene glycol.
Diabetes 1997;46(3):440–450
Article history
Received:
June 28 1996
Revision Received:
October 17 1996
Accepted:
October 17 1996
PubMed:
9032100
Citation
Bernard Zinman, Hugh Tildesley, Jean-Louis Chiasson, Elaine Tsui, Thomas Strack; Insulin Lispro in CSII: Results of a Double-Blind Crossover Study. Diabetes 1 March 1997; 46 (3): 440–450. https://doi.org/10.2337/diab.46.3.440
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