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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00607087




Registration number
NCT00607087
Ethics application status
Date submitted
23/01/2008
Date registered
5/02/2008
Date last updated
31/08/2010

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2007-003579-38
Secondary ID [2] 0 0
APIDR_C_02083
Universal Trial Number (UTN)
Trial acronym
PUMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin glulisine
Treatment: Drugs - Insulin lispro
Treatment: Drugs - Insulin aspart

Experimental: sequence 1 - sequence 1: insulin glulisine / insulin aspart / insulin lispro.

Experimental: Sequence 2 - Sequence 2: insulin aspart / insulin lispro / insulin glulisine

Experimental: Sequence 3 - Sequence 3: insulin lispro / insulin glulisine / insulin aspart


Treatment: Drugs: Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Treatment: Drugs: Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Treatment: Drugs: Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Timepoint [1] 0 0
over 13 weeks of each treatment period
Secondary outcome [1] 0 0
Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Timepoint [1] 0 0
over 13 weeks of each treatment period
Secondary outcome [2] 0 0
Percentage of Patients With at Least One Unexplained Hyperglycemia
Timepoint [2] 0 0
over 13 weeks of each treatment period
Secondary outcome [3] 0 0
Monthly Rate of Unexplained Hyperglycemia
Timepoint [3] 0 0
over 13 weeks of each treatment period
Secondary outcome [4] 0 0
Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
Timepoint [4] 0 0
over 13 weeks of each treatment period
Secondary outcome [5] 0 0
Monthly Rate of Confirmed Infusion Set Occlusion
Timepoint [5] 0 0
over 13 weeks of each treatment period
Secondary outcome [6] 0 0
Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Timepoint [6] 0 0
over 13 weeks of each treatment period
Secondary outcome [7] 0 0
Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Timepoint [7] 0 0
over 13 weeks of each treatment period
Secondary outcome [8] 0 0
Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) = 70 mg/dL Per Patient-year
Timepoint [8] 0 0
over 13 weeks of each treatment period
Secondary outcome [9] 0 0
Rate of Severe Symptomatic Hypoglycemia Per Patient-year
Timepoint [9] 0 0
over 13 weeks of each treatment period
Secondary outcome [10] 0 0
Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) =70 mg/dL Per Patient-year
Timepoint [10] 0 0
over 13 weeks of each treatment period
Secondary outcome [11] 0 0
Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
Timepoint [11] 0 0
over 13 weeks of each treatment period
Secondary outcome [12] 0 0
Time Interval Between Infusion Set Changes: All Changes
Timepoint [12] 0 0
over 13 weeks of each treatment period
Secondary outcome [13] 0 0
Time Interval Between Infusion Set Changes in Routine
Timepoint [13] 0 0
over 13 weeks of each treatment period
Secondary outcome [14] 0 0
Glycosylated Hemoglobin: HbA1c
Timepoint [14] 0 0
over 13 weeks of each treatment period
Secondary outcome [15] 0 0
Total Daily Basal Insulin Infusion
Timepoint [15] 0 0
over 13 weeks of each treatment period
Secondary outcome [16] 0 0
Total Daily Bolus Insulin Dose
Timepoint [16] 0 0
over 13 weeks of each treatment period

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Israel
State/province [5] 0 0
Natanya
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Netherlands
State/province [8] 0 0
PE Gouda
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Sweden
State/province [10] 0 0
Bromma
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Affairs
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00607087