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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 (PUMP)
This study is ongoing, but not recruiting participants.
First Received: January 23, 2008   Last Updated: June 5, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00607087
  Purpose

Primary: 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.

Secondary:

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.
  • Site infection, site inflammation / erythema, pruritis and isolated pain at injection site
  • Overall safety: incidence of adverse events
  • Change in body weight

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Insulin glulisine
Drug: Insulin lispro
Drug: Insulin aspart
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Episodes of unexplained hyperglycemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Episodes of infusion set occlusion. [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Time to change the infusion set and reservoir [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Local infection requiring drainage [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Adverse events, vital signs [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]
  • Laboratory Fasting Plasma Glucose (FPG) and HbA1c, Body weight [ Time Frame: At week 0, week 13, week 26 and week 39 ] [ Designated as safety issue: No ]
  • Insulin doses [ Time Frame: At specific time points ] [ Designated as safety issue: No ]
  • Self-monitored blood glucose values [ Time Frame: At specific time points ] [ Designated as safety issue: No ]
  • Episodes of ketosis and diabetes ketoacidosis [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: January 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
2: Active Comparator Drug: Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
3: Active Comparator Drug: Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 ophtalmoscopic 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607087

Locations
United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States
Australia
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Austria
Sanofi-aventis Administrative Office
Vienna, Austria
France
Sanofi-aventis Administrative Office
Paris, France
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-aventis Administrative Office
Natanya, Israel
Italy
Sanofi-aventis Administrative Office
Milan, Italy
Korea, Republic of
Sanofi-aventis Administrative Office
Seoul, Korea, Republic of
Netherlands
Sanofi-aventis Administrative Office
PE Gouda, Netherlands
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Bertrand Alexandre, MD Sanofi-Aventis
  More Information

No publications provided

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: APIDR_C_02083, EUDRACT # 2007-003579-38
Study First Received: January 23, 2008
Last Updated: June 5, 2009
ClinicalTrials.gov Identifier: NCT00607087     History of Changes
Health Authority: Sweden: Regional Ethical Review Board

Study placed in the following topic categories:
Metabolic Diseases
Autoimmune Diseases
Insulin glulisine
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Diabetes Mellitus Type 1
Insulin
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Autoimmune Diseases
Insulin glulisine
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Pharmacologic Actions
Insulin
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009