Insulin Glulisine Compared to Insulin Aspart and to Insulin Lispro Administered by Continuous Subcutaneous Insulin Infusion in Patients with Type 1 Diabetes: A Randomized Controlled Trial

van Bon, Arianne C.; Bode, Bruce W.; Sert-Langeron, Caroline; DeVries, J. Hans; Charpentier, Guillaume

doi:10.1089/dia.2010.0224

Cited by 96Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes Management and Education

Insulin Glulisine Compared to Insulin Aspart and to Insulin Lispro Administered by Continuous Subcutaneous Insulin Infusion in Patients with Type 1 Diabetes: A Randomized Controlled Trial

van Bon, Arianne C., Bode, Bruce W., Sert-Langeron, Caroline, DeVries, J. Hans, Charpentier, Guillaume·2011·Diabetes Technology & Therapeutics

DOI 10.1089/dia.2010.0224

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Abstract

Background In a previous pilot study comparing insulin glulisine (GLU) with insulin aspart (ASP) administered by continuous subcutaneous insulin infusion (CSII), GLU-treated patients did show a trend toward fewer catheter occlusions compared with ASP-treated patients. Here we performed a randomized open-label, three-way crossover, controlled multicenter study comparing GLU with ASP and insulin lispro (LIS). Methods Subjects with type 1 diabetes were allocated to one of three treatment orders-GLU-ASP-LIS, ASP-LIS-GLU, or LIS-GLU-ASP-with each insulin used for 13 weeks. The study was designed to demonstrate the superiority of GLU over ASP and LIS on unexplained hyperglycemia and/or perceived infusion set occlusion. A prespecified P value of 0.025 was considered significant to correct for multiple testing. Results Percentages of subjects with at least one unexplained hyperglycemia and/or infusion set occlusion were not significantly different between GLU and ASP (68.4% [62.7-74.1%] vs. 62.1% [56.2-68.1%], P = 0.04) and GLU and LIS (68.4% [62.7-74.1%] vs. 61.3% [55.4-67.3%], P = 0.03). No differences were seen in hemoglobin A1c at end point, most points of the seven-point glucose curves, severe hypoglycemia, and symptomatic ketoacidosis. The overall rate of hypoglycemia with a plasma glucose level below 70 mg/dL per patient-year was significantly different between GLU and ASP (73.84 vs. 65.01, P = 0.008) and GLU and LIS (73.84 vs. 62.69, P Conclusions GLU was not superior to ASP…

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A definite link between the frequency of insulin pump occlusions and elevation of A1C has not been demonstrated.
“Insulin pump occlusions are felt by many diabetes professionals to impair blood glucose control,1 although a definite link between occlusion frequency and elevation of A1C has not been demonstrated.2,3”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [2]
At the end of that study, each subject had used all three analogs.
“At the end of the study they had each used all three analogs.”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [2]
For the multivariate statistical analysis, P was set at the .025 level for treatment effect.
“For the multivariate statistical analysis, P was set at the .025 level for treatment effect.2”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [2]
In a follow-up study comparing the occlusion rate of pumps delivering GLU against those of both ASP and LIS, 256 subjects with type 1 diabetes received three sequences of insulin analogs, each for 13 weeks for a total of 39 weeks.
“In a follow-up study comparing the occlusion rate of pumps delivering GLU against those of both APS and LIS, 256 subjects with type 1 diabetes received three sequences of insulin analogs, each for 13 weeks for a total of 39 weeks.”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [2]
Percentages of subjects with at least one unexplained hyperglycemia and/or IIS occlusion were not significantly different between GLU and ASP (68.4% vs 62.1%, P = .04) and between GLU and LIS (68.4% vs 61.3%, P = .03).
“Percentages of subjects with at least one unexplained hyperglycemia and/or IIS occlusion were not significantly different between GLU and ASP (68.4% vs 62.1%, P = .04) and between GLU and LIS (68.4% vs 61.3%, P = .03).”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [2]

Other limitations include the use of trained nurses to manage insertions, relatively short duration of infusions, and limited ambulatory activities, which might not reflect the true prevalence of pressure-related or leakage events.
“Other limitations, including the use of trained nurses to manage insertions rather than the subject, relatively short duration of infusions, and limited ambulatory activities by subjects, might not reflect the true prevalence of pressure-related or leakage events and unexplained hyperglycemia as reported by others9,16 but are inherent to the nature of the investigations performed.”
From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as [9]
Reports of CSII delivery irregularities, where patients experience elevations in blood glucose levels that may or may not respond to a correction bolus, have been underappreciated.
“Additionally, reports of CSII delivery irregularities, where patients experience elevations in blood glucose levels that may or may not respond to a correction bolus (often called “unexplained hyperglycemia”), have been underappreciated.9”
From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as [9]
Approximately 60% of patients with type 1 diabetes using CSII experienced at least one episode of unexplained hyperglycemia during a 13-week study period, and 30% experienced an occlusion alarm.
“van Bon et al.9 reported that approximately 60% of patients with type 1 diabetes using CSII experienced at least one episode of unexplained hyperglycemia during a 13-week study period, and 30% of subjects experienced an occlusion alarm.”
From Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies (2016) · cites this paper as van Bon et al. [9]

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A comparison of the rapid-acting insulin analogue glulisine with lispro and aspart for the pump treatment of patients with type 1 diabetes
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Insulin Lispro with Continuous Subcutaneous Insulin Infusion is Safe and Effective in Patients With Type 2 Diabetes: A Randomized Crossover Trial of Insulin Lispro Versus Insulin Aspart
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Better Postprandial Glucose Stability During Continuous Subcutaneous Infusion with Insulin Aspart Compared with Insulin Lispro in Patients with Type 1 Diabetes
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Authors: van Bon, A. C., Bode, B. W., Sert-Langeron, C., DeVries, J. H., & Charpentier, G.
Affiliations: Academic Medical Center
Emory University (US)
Sanofi (France) (FR)
Amsterdam UMC Location University of Amsterdam (NL)
Centre Hospitalier Sud Francilien (FR)
Corresponding author: DeVries, J. Hans
ORCID: Bode, Bruce W.
DeVries, J. Hans
Charpentier, Guillaume
Venue: Diabetes Technology & Therapeutics
Publisher: SAGE Publications
Published: 2011-06
Volume: 13
Issue: 6
Pages: 607-614
ISSN: 1520-9156 (ISSN-L)
1557-8593
DOI: 10.1089/dia.2010.0224
OpenAlex: W2002371885
Cited by: 96
References: 7
Citations by year: 2026: 1 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 9 · 2021: 4 · 2020: 6 · 2019: 5 · 2018: 13 · 2017: 5 · 2016: 7 · 2015: 9 · 2014: 10 · 2013: 4 · 2012: 9
FWCI: 7.08
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Diabetes Technology & Therapeutics (publishedVersion)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: Sanofi
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords: insulin glulisine, insulin aspart, insulin lispro, insulin pump therapy, type 1 diabetes, hypoglycemia, HbA1c, insulin analogues, insulin dose, glucose curves, insulin overdose, catheter occlusion prevention
MeSH terms: Adult, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Statistics as Topic, Time Factors, Diabetic Ketoacidosis, Cross-Over Studies, Insulin Aspart, Insulin Lispro

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Insulin Glulisine Compared to Insulin Aspart and to Insulin Lispro Administered by Continuous Subcutaneous Insulin Infusion in Patients with Type 1 Diabetes: A Randomized Controlled Trial

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