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 - ND

• Conditions: Type I Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2007-003579-38-IT
• Lead Sponsor: SANOFI AVENTIS GROUPE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Men or women, aged from 18 to 75 years inclusive 2. Type 1 diabetic subjects 3. Treated with insulin for at least 2 years and by CSII for at least 6 months 4. 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 5. Using the same type of infusion set (catheter and cannula) for at least 3 months 6. Performing at least 3 blood glucose controls per day 7. HbA1c < 8.5% 8. Body mass index (BMI) < 35 kg/m2 9. Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home 10. Written informed consent obtained prior to enrolment in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diabetes other than Type 1 2. Total daily dose of insulin greater than 90 U/day 3. Using an insulin pump requiring pre-filled cartridges 4. History of infection at infusion site requiring a drainage in the last 3 months 5. History of severe episodes of ketosis requiring hospitalization in the last 6 months 6. 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 ophtalmoscopic examination should have been performed in the 2 years prior to study entry 7. Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding 8. Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1 9. Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1 10. Likelihood of requiring treatments during the study which are not permitted 11. Treatment with an investigational product in the 30 days prior to visit 1 12. History of sensitivity to the study drugs or to drugs with a similar chemical structure 13. 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 14. Night shift workers 15. 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 16. Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart aminotransferase (AST) greater than three times the upper limit of normal range) 17. Alcohol or drug abuse in the last year 18. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 19. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikehood of completing the study 20. Patient is the Investigator or any sub-Investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified