Type I Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Apidra®
Product Name: insulin glulisine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glulisine
Concentration unit: U/ml unit(s)/millilitre
Concentration type: e
Sponsors
sanofi-aventis groupe
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess 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. For the purpose of the study, the infusion set will always be referred to as the catheter and the cannula. ;Secondary Objective: To compare insulin glulisine, insulin aspart and insulin lispro on: • Unexplained hyperglycemia • Infusion set occlusion • HbA1c, hypoglycemic episodes, 7-point blood glucose profiles, episodes of ketosis and ketoacidosis • Insulin doses (total, basal, bolus) • Time to change the infusion set. The infusion set and the reservoir will always be replaced at the same time, either on a routine basis or when occlusion occurs or is suspected • Site infection, site inflammation / erythema, pruritis and isolated pain at injection site • Overall safety: incidence of adverse events • Change in body weight;Primary end point(s): Data collected for the assessment of primary and main secondary endpoints - All across the study • Episodes of unexplained hyperglycemia, i.e. Plasma Glucose (PG) above 300 mg/dL (16.7 mmol/L) with no apparent medical or dietary reason, inappropriate insulin dose or pump failure • Episodes of infusion set occlusion. Signs of occlusion can be: Pump occlusion alarm Patient observation of occlusion • Time to change the infusion set and reservoir • Abscess (local infection requiring drainage), site infection requiring local and/or general antibiotherapy, site inflammation /erythema (no local and/or general antibiotherapy required), pruritis or isolated pain at injection site • Episodes of ketosis and diabetes ketoacidosis (DKA), as defined by an elevated ketone value in the blood (fingertip) associated with hyperglycemia (PG above 300 mg/dL [16.7 mmol/L]) • Hypoglycemia (symptomatic diurnal and nocturnal, severe, asymptomatic). • Safety data: adverse events, vital signs - At specific time points • Laborat | — |
Countries
Austria, France, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed