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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 currently recruiting participants.
Verified by Sanofi-Aventis, July 2008

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

MedlinePlus related topics:   Diabetes    Diabetes Type 1   

ChemIDplus related topics:   Insulin    Insulin aspart    Insulin lispro    Insulin glulisine   

U.S. FDA Resources

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

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:   270
Study Start Date:   January 2008
Estimated Primary Completion Date:   April 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

Contacts
Contact: Public Registry GMA     PublicRegistryGMA@sanofi-aventis.com    

Locations
United States, New Jersey
Sanofi-aventis     Active, not recruiting
      Bridgewater, New Jersey, United States
Australia
Sanofi-aventis     Recruiting
      MacQuarie Park, Australia
Austria
Sanofi-aventis     Recruiting
      Wien, Austria
France
Sanofi-aventis     Recruiting
      Paris, France
Hungary
Sanofi-aventis     Not yet recruiting
      Budapest, Hungary
Israel
Sanofi-aventis     Recruiting
      Natanya, Israel
Italy
Sanofi-aventis     Not yet recruiting
      Milan, Italy
Korea, Republic of
Sanofi-aventis     Recruiting
      Seoul, Korea, Republic of
Netherlands
Sanofi-aventis     Recruiting
      Gouda, Netherlands
Spain
Sanofi-aventis     Recruiting
      Barcelona, Spain
Sweden
Sanofi-aventis     Recruiting
      Bromma, Sweden
United Kingdom
Sanofi-aventis     Recruiting
      Guildford, United Kingdom

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Bertrand Alexandre, MD     Sanofi-Aventis    
  More Information

Responsible Party:   sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:   APIDR_C_02083, EUDRACT # 2007-003579-38
First Received:   January 23, 2008
Last Updated:   July 2, 2008
ClinicalTrials.gov Identifier:   NCT00607087
Health Authority:   Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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