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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 1

In brief

Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. 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

Key facts

Study ID: NCT00607087
Run by: Sanofi
People needed: 289
Starts: 2008-01-01
Expected to finish: 2009-06-01
Last updated by the study team: 2010-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Type 1 diabetic subjects
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

You may not qualify if…

Diabetes other than Type 1
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.

Where it is running

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

Full record on ClinicalTrials.gov

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