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Trial record 26 of 78 for:    sanofi-aventis and sweden

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607087
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : July 30, 2010
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Insulin glulisine
Drug: Insulin lispro
Drug: Insulin aspart
Enrollment 289
Recruitment Details Multicenter study: 44 active centers from 12 countries in Europe, USA and Asia Pacific region. Study Initiation date: January 8, 2008, Study Completion Date: June 15, 2009.
Pre-assignment Details

359 participants screened; 289 randomized; 288 patients treated (1 patient not treated per physician's decision): 274 with insulin glulisine, 269 with insulin lispro, 266 with insulin aspart.

The safety population, (N=288 patients randomized and treated) is described in the participant flow and baseline characteristics.

Arm/Group Title Sequence 1 Sequence 2 Sequence 3
Hide Arm/Group Description insulin glulisine / insulin aspart / insulin lispro insulin aspart / insulin lispro / insulin glulisine insulin lispro / insulin glulisine / insulin aspart
Period Title: Overall Study
Started 99 95 94
Completed 84 84 84
Not Completed 15 11 10
Reason Not Completed
Withdrawal by Subject             9             4             4
Adverse Event             3             2             3
Other reason             1             5             2
Poor compliance to protocol             1             0             1
Lost to Follow-up             1             0             0
Period Title: Period 1
Started 99 95 94
Completed 87 89 89
Not Completed 12 6 5
Reason Not Completed
Withdrawal by Subject             7             2             3
Adverse Event             3             0             0
Poor compliance to protocol             1             0             0
Lost to Follow-up             1             0             0
Other reason             0             4             2
Period Title: Period 2
Started 87 89 89
Completed 86 86 84
Not Completed 1 3 5
Reason Not Completed
Withdrawal by Subject             0             1             1
Other reason             1             1             0
Adverse Event             0             1             3
Poor compliance to protocol             0             0             1
Period Title: Period 3
Started 86 86 84
Completed 84 84 84
Not Completed 2 2 0
Reason Not Completed
Withdrawal by Subject             2             1             0
Adverse Event             0             1             0
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Total
Hide Arm/Group Description insulin glulisine / insulin aspart / insulin lispro insulin aspart / insulin lispro / insulin glulisine insulin lispro / insulin glulisine / insulin aspart Total of all reporting groups
Overall Number of Baseline Participants 99 95 94 288
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 95 participants 94 participants 288 participants
43.45  (13.71) 45.84  (13.59) 44.04  (12.87) 44.43  (13.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 95 participants 94 participants 288 participants
Female
49
  49.5%
54
  56.8%
48
  51.1%
151
  52.4%
Male
50
  50.5%
41
  43.2%
46
  48.9%
137
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 95 participants 94 participants 288 participants
United States 22 21 21 64
France 8 9 10 27
Hungary 4 4 6 14
Spain 11 9 10 30
Austria 7 9 8 24
Australia 4 4 3 11
Israel 11 11 10 32
Netherlands 8 8 7 23
United Kingdom 5 4 4 13
Italy 9 7 7 23
Sweden 9 8 7 24
Korea, Republic of 1 1 1 3
Previous insulin at study entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 95 participants 94 participants 288 participants
Insulin glulisine 4 2 2 8
Insulin aspart 32 43 42 117
Insulin lispro 63 49 50 162
[1]
Measure Description: Total patients analyzed n=287 due to one missing data in the "sequence 2" group
Duration of treatment with previous insulin at study entry   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 95 participants 94 participants 288 participants
4.84  (3.58) 4.37  (3.05) 4.79  (3.00) 4.67  (3.22)
[1]
Measure Description: Total patients analyzed n=286 due to one missing data in the "sequence 1" and in the "sequence 2" groups
Duration of treatment with insulin at study entry  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 95 participants 94 participants 288 participants
22.39  (13.53) 23.07  (13.33) 22.75  (11.08) 22.73  (12.67)
Total daily bolus insulin dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units
Number Analyzed 99 participants 95 participants 94 participants 288 participants
19.61  (9.40) 18.58  (10.34) 19.35  (7.78) 19.18  (9.22)
[1]
Measure Description: Total patients analyzed n=285 due to 3 missing data: 2 in the "sequence 1" and 1 in the "sequence 2" groups
Duration of treatment with CSII (continuous subcutaneous insulin infusion) at study entry  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 95 participants 94 participants 288 participants
5.99  (4.83) 5.52  (5.27) 6.31  (4.95) 5.94  (5.01)
Total daily basal insulin infusion   [1] 
Mean (Standard Deviation)
Unit of measure:  Units
Number Analyzed 99 participants 95 participants 94 participants 288 participants
20.98  (8.84) 19.99  (9.38) 22.03  (9.17) 21.00  (9.13)
[1]
Measure Description: Total patients analyzed n=285 due to 3 missing data: 2 in the "sequence 1" and 1 in the "sequence 2" groups
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 99 participants 95 participants 94 participants 288 participants
25.01  (3.53) 25.25  (3.91) 25.92  (3.98) 25.39  (3.81)
Central fasting plasma glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 99 participants 95 participants 94 participants 288 participants
149.84  (59.03) 147.45  (61.63) 151.18  (64.06) 149.48  (61.37)
[1]
Measure Description: Total patients analyzed n=284 due to 4 missing data: 2 in the "sequence 1" and 2 in the "sequence 3" groups
Glycosylated Haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 99 participants 95 participants 94 participants 288 participants
7.38  (0.69) 7.36  (0.61) 7.41  (0.69) 7.38  (0.66)
1.Primary Outcome
Title Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Hide Description

Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.

Pump infusion set occlusion defined by at least one of the following items:

  • pump occlusion alarm,
  • patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
68.4
(62.7 to 74.1)
62.1
(56.2 to 68.1)
61.3
(55.4 to 67.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025.
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
Hide Description

Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.

Pump infusion set occlusion defined by at least one of the following items:

  • pump occlusion alarm,
  • patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events per patient per month
2.02  (0.15) 1.32  (0.15) 1.54  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients With at Least One Unexplained Hyperglycemia
Hide Description Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
61.3
(55.4 to 67.3)
55.9
(49.8 to 61.9)
56.3
(50.2 to 62.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title Monthly Rate of Unexplained Hyperglycemia
Hide Description [Not Specified]
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events per patient per month
1.61  (0.13) 1.04  (0.13) 1.23  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
Hide Description

Pump infusion set occlusion defined by at least one of the following items:

  • pump occlusion alarm,
  • patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
32.8
(27.1 to 38.6)
27.0
(21.5 to 32.4)
27.0
(21.5 to 32.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
6.Secondary Outcome
Title Monthly Rate of Confirmed Infusion Set Occlusion
Hide Description [Not Specified]
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events per patient per month
0.41  (0.06) 0.28  (0.06) 0.31  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Hide Description

Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).

Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l

Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
17.6
(12.9 to 22.2)
10.9
(7.1 to 14.8)
11.7
(7.8 to 15.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
8.Secondary Outcome
Title Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
Hide Description

Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).

Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l

Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events per patient per month
0.14  (0.43) 0.06  (0.22) 0.06  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year
Hide Description Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events in patient-year
73.88  (4.74) 65.06  (4.74) 62.74  (4.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Rate of Severe Symptomatic Hypoglycemia Per Patient-year
Hide Description

Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:

  • the event was associated with a measured blood glucose level below 36 mg/dL
  • or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events in patient-year
1.63  (0.35) 1.39  (0.35) 1.07  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year
Hide Description Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Error)
Unit of Measure: events in patient-year
12.80  (0.95) 9.66  (0.95) 9.48  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
Hide Description

Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.

Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.

Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.

Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection.

Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Measure Type: Number
Unit of Measure: patients
110 110 107
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method McNemar
Comments [Not Specified]
13.Secondary Outcome
Title Time Interval Between Infusion Set Changes: All Changes
Hide Description

Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).

"All changes" include all the changes whatever the reason such as routine or requested by occurrence of events.

Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 254 254 254
Mean (Standard Deviation)
Unit of Measure: hours
69.1  (20.70) 69.44  (19.22) 69.98  (21.64)
14.Secondary Outcome
Title Time Interval Between Infusion Set Changes in Routine
Hide Description

Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).

Changes in routine correspond to interval between changes according to patient use.

Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 254 254 254
Mean (Standard Deviation)
Unit of Measure: hours
70.72  (21.47) 71.00  (20.68) 71.07  (21.65)
15.Secondary Outcome
Title Glycosylated Hemoglobin: HbA1c
Hide Description Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Deviation)
Unit of Measure: percentage
First week (week 1) (n=253, n=254, n=255) 7.31  (0.71) 7.33  (0.71) 7.28  (0.71)
Last week (week 13) (n=252, n=255, n=251) 7.32  (0.03) 7.25  (0.03) 7.33  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Aspart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method ANCOVA
Comments ANCOVA adjusted on HbA1c value at the start of the first period
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Glulisine, Insulin Lispro
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.938
Comments The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025
Method ANCOVA
Comments ANCOVA adjusted on HbA1c level at the start of the first period
16.Secondary Outcome
Title Total Daily Basal Insulin Infusion
Hide Description dose of the basal insulin regimen administered throughout the 24-hour period
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Deviation)
Unit of Measure: Units
First week (week 1) (n=251, n=249, n=250) 20.83  (9.05) 20.93  (9.45) 20.85  (9.16)
Last week (week 13) (n=251, n=249, n=251) 20.86  (9.24) 20.81  (9.73) 21.11  (9.38)
17.Secondary Outcome
Title Total Daily Bolus Insulin Dose
Hide Description dose of every increment administered for example before meals
Time Frame over 13 weeks of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description:
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Overall Number of Participants Analyzed 256 256 256
Mean (Standard Deviation)
Unit of Measure: Units
First week (week 1) (n=249, n=247, n=250) 18.63  (9.22) 18.49  (9.00) 18.40  (8.69)
Last week (week 13) (n=248, n=244, n=249) 18.58  (8.49) 18.64  (9.60) 19.19  (9.13)
Time Frame Adverse events are collected from the first to the last drug intake (3 periods x 13 weeks) + 1 week after the administration of the last intake i.e. end of the study.
Adverse Event Reporting Description The safety analyses are performed on the safety population which includes all randomized and treated patients. Safety population is defined based on actual treatment received.
 
Arm/Group Title Insulin Glulisine Insulin Aspart Insulin Lispro
Hide Arm/Group Description 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
All-Cause Mortality
Insulin Glulisine Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Glulisine Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/274 (10.58%)   18/266 (6.77%)   11/269 (4.09%) 
Cardiac disorders       
arteritis coronary * 1  0/274 (0.00%)  1/266 (0.38%)  0/269 (0.00%) 
cardiovascular disorders * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
coronary artery stenosis * 1  0/274 (0.00%)  1/266 (0.38%)  0/269 (0.00%) 
myocardial infarction * 1  0/274 (0.00%)  1/266 (0.38%)  0/269 (0.00%) 
Ear and labyrinth disorders       
vertigo * 1  0/274 (0.00%)  0/266 (0.00%)  1/269 (0.37%) 
General disorders       
chest pain * 1  1/274 (0.36%)  1/266 (0.38%)  0/269 (0.00%) 
Injury, poisoning and procedural complications       
overdose * 1  1/274 (0.36%)  1/266 (0.38%)  0/269 (0.00%) 
forearm fracture * 1  0/274 (0.00%)  0/266 (0.00%)  1/269 (0.37%) 
Metabolism and nutrition disorders       
hypoglycaemic seizure * 1  8/274 (2.92%)  3/266 (1.13%)  4/269 (1.49%) 
ketosis * 1  9/274 (3.28%)  4/266 (1.50%)  2/269 (0.74%) 
hypoglycaemic unconsciousness * 1  4/274 (1.46%)  6/266 (2.26%)  2/269 (0.74%) 
hypoglycaemia * 1  3/274 (1.09%)  0/266 (0.00%)  0/269 (0.00%) 
diabetic ketoacidosis * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
Nervous system disorders       
headache * 1  0/274 (0.00%)  1/266 (0.38%)  0/269 (0.00%) 
hemianopia * 1  0/274 (0.00%)  0/266 (0.00%)  1/269 (0.37%) 
hypoglycaemic coma * 1  0/274 (0.00%)  1/266 (0.38%)  0/269 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
pregnancy * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
Psychiatric disorders       
depression * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
dyspnoea * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
nasal congestion * 1  1/274 (0.36%)  0/266 (0.00%)  0/269 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin Glulisine Insulin Aspart Insulin Lispro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   47/274 (17.15%)   24/266 (9.02%)   30/269 (11.15%) 
Metabolism and nutrition disorders       
Ketosis * 1  47/274 (17.15%)  24/266 (9.02%)  30/269 (11.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Study Director
Organization: sanofi-aventis
EMail: publicregistryGMA@sanofi-aventis.com
Layout table for additonal information
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00607087     History of Changes
Other Study ID Numbers: APIDR_C_02083
2007-003579-38 ( EudraCT Number )
First Submitted: January 23, 2008
First Posted: February 5, 2008
Results First Submitted: June 30, 2010
Results First Posted: July 30, 2010
Last Update Posted: August 31, 2010