Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
NCT ID: NCT00607087
Last Updated: 2010-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
289 participants
INTERVENTIONAL
2008-01-31
2009-06-30
Brief Summary
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Main Secondary objectives:
To compare insulin glulisine, insulin aspart and insulin lispro on:
* Unexplained hyperglycemia
* Infusion set occlusion
* Hypoglycemic episodes,7-point blood glucose profiles
* Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
* Time to change the infusion set
* HbA1c (Glycosylated hemoglobin)
* Overall safety: incidence of adverse events
Detailed Description
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* a 2-week screening period,
* a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
* and a follow-up period of 24 hours.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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sequence 1
sequence 1: insulin glulisine / insulin aspart / insulin lispro.
Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Sequence 2
Sequence 2: insulin aspart / insulin lispro / insulin glulisine
Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Sequence 3
Sequence 3: insulin lispro / insulin glulisine / insulin aspart
Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Interventions
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Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Eligibility Criteria
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Inclusion Criteria
* Treated with insulin for at least 2 years and by CSII for at least 6 months
* Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII for at least 3 months with the same external pump compatible with the 3 short acting insulin analogues used in the study
* Using the same type of infusion set (catheter and cannula) for at least 3 months
* Performing at least 3 blood glucose controls per day
* HbA1c \< 8.5%
* Body mass index (BMI) \< 35 kg/m²
* Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home
Exclusion Criteria
* Total daily dose of insulin greater than 90 U/day
* Using an insulin pump requiring pre-filled cartridges
* History of infection at infusion site requiring a drainage in the last 3 months
* History of severe episodes of ketosis requiring hospitalization in the last 6 months
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study. An ophthalmoscopic examination should have been performed in the 2 years prior to study entry
* Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding
* Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1
* Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1
* Likelihood of requiring treatments during the study which are not permitted
* Treatment with an investigational product in the 30 days prior to visit 1
* History of sensitivity to the study drugs or to drugs with a similar chemical structure
* Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the Investigator feels would compromise the patient safety or limit his/her successful participation in the study
* Night shift workers
* Impaired renal function as shown by serum creatinine ≥1.5 mg/dL (133 μmol/L) or ≥1.4 mg/dL (124 μmol/L) in men and women, respectively
* Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart aminotransferase (AST) greater than three times the upper limit of normal range)
* Alcohol or drug abuse in the last year
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Medical Affairs
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Macquarie Park, , Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
PE Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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References
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van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G. 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. Diabetes Technol Ther. 2011 Jun;13(6):607-14. doi: 10.1089/dia.2010.0224. Epub 2011 Apr 2.
Other Identifiers
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2007-003579-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APIDR_C_02083
Identifier Type: -
Identifier Source: org_study_id