Trial Outcomes & Findings for 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 (NCT NCT00607087)
NCT ID: NCT00607087
Last Updated: 2010-08-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
289 participants
Primary outcome timeframe
over 13 weeks of each treatment period
Results posted on
2010-08-31
Participant Flow
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.
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.
Participant milestones
| Measure |
Sequence 1
insulin glulisine / insulin aspart / insulin lispro
|
Sequence 2
insulin aspart / insulin lispro / insulin glulisine
|
Sequence 3
insulin lispro / insulin glulisine / insulin aspart
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
95
|
94
|
|
Overall Study
COMPLETED
|
84
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
10
|
|
Period 1
STARTED
|
99
|
95
|
94
|
|
Period 1
COMPLETED
|
87
|
89
|
89
|
|
Period 1
NOT COMPLETED
|
12
|
6
|
5
|
|
Period 2
STARTED
|
87
|
89
|
89
|
|
Period 2
COMPLETED
|
86
|
86
|
84
|
|
Period 2
NOT COMPLETED
|
1
|
3
|
5
|
|
Period 3
STARTED
|
86
|
86
|
84
|
|
Period 3
COMPLETED
|
84
|
84
|
84
|
|
Period 3
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
insulin glulisine / insulin aspart / insulin lispro
|
Sequence 2
insulin aspart / insulin lispro / insulin glulisine
|
Sequence 3
insulin lispro / insulin glulisine / insulin aspart
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
4
|
|
Overall Study
Adverse Event
|
3
|
2
|
3
|
|
Overall Study
Other reason
|
1
|
5
|
2
|
|
Overall Study
Poor compliance to protocol
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
7
|
2
|
3
|
|
Period 1
Adverse Event
|
3
|
0
|
0
|
|
Period 1
Poor compliance to protocol
|
1
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
0
|
|
Period 1
Other reason
|
0
|
4
|
2
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
1
|
|
Period 2
Other reason
|
1
|
1
|
0
|
|
Period 2
Adverse Event
|
0
|
1
|
3
|
|
Period 2
Poor compliance to protocol
|
0
|
0
|
1
|
|
Period 3
Withdrawal by Subject
|
2
|
1
|
0
|
|
Period 3
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Sequence 1
n=99 Participants
insulin glulisine / insulin aspart / insulin lispro
|
Sequence 2
n=95 Participants
insulin aspart / insulin lispro / insulin glulisine
|
Sequence 3
n=94 Participants
insulin lispro / insulin glulisine / insulin aspart
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
43.45 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
45.84 years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
44.04 years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
44.43 years
STANDARD_DEVIATION 13.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Previous insulin at study entry
Insulin glulisine
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Previous insulin at study entry
Insulin aspart
|
32 participants
n=5 Participants
|
43 participants
n=7 Participants
|
42 participants
n=5 Participants
|
117 participants
n=4 Participants
|
|
Previous insulin at study entry
Insulin lispro
|
63 participants
n=5 Participants
|
49 participants
n=7 Participants
|
50 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Duration of treatment with previous insulin at study entry
|
4.84 years
STANDARD_DEVIATION 3.58 • n=5 Participants
|
4.37 years
STANDARD_DEVIATION 3.05 • n=7 Participants
|
4.79 years
STANDARD_DEVIATION 3.00 • n=5 Participants
|
4.67 years
STANDARD_DEVIATION 3.22 • n=4 Participants
|
|
Duration of treatment with insulin at study entry
|
22.39 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
23.07 years
STANDARD_DEVIATION 13.33 • n=7 Participants
|
22.75 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
22.73 years
STANDARD_DEVIATION 12.67 • n=4 Participants
|
|
Total daily bolus insulin dose
|
19.61 Units
STANDARD_DEVIATION 9.40 • n=5 Participants
|
18.58 Units
STANDARD_DEVIATION 10.34 • n=7 Participants
|
19.35 Units
STANDARD_DEVIATION 7.78 • n=5 Participants
|
19.18 Units
STANDARD_DEVIATION 9.22 • n=4 Participants
|
|
Duration of treatment with CSII (continuous subcutaneous insulin infusion) at study entry
|
5.99 years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
5.52 years
STANDARD_DEVIATION 5.27 • n=7 Participants
|
6.31 years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
5.94 years
STANDARD_DEVIATION 5.01 • n=4 Participants
|
|
Total daily basal insulin infusion
|
20.98 Units
STANDARD_DEVIATION 8.84 • n=5 Participants
|
19.99 Units
STANDARD_DEVIATION 9.38 • n=7 Participants
|
22.03 Units
STANDARD_DEVIATION 9.17 • n=5 Participants
|
21.00 Units
STANDARD_DEVIATION 9.13 • n=4 Participants
|
|
Body Mass Index (BMI)
|
25.01 kg/m²
STANDARD_DEVIATION 3.53 • n=5 Participants
|
25.25 kg/m²
STANDARD_DEVIATION 3.91 • n=7 Participants
|
25.92 kg/m²
STANDARD_DEVIATION 3.98 • n=5 Participants
|
25.39 kg/m²
STANDARD_DEVIATION 3.81 • n=4 Participants
|
|
Central fasting plasma glucose
|
149.84 mg/dL
STANDARD_DEVIATION 59.03 • n=5 Participants
|
147.45 mg/dL
STANDARD_DEVIATION 61.63 • n=7 Participants
|
151.18 mg/dL
STANDARD_DEVIATION 64.06 • n=5 Participants
|
149.48 mg/dL
STANDARD_DEVIATION 61.37 • n=4 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
7.38 Percent
STANDARD_DEVIATION 0.69 • n=5 Participants
|
7.36 Percent
STANDARD_DEVIATION 0.61 • n=7 Participants
|
7.41 Percent
STANDARD_DEVIATION 0.69 • n=5 Participants
|
7.38 Percent
STANDARD_DEVIATION 0.66 • n=4 Participants
|
PRIMARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
|
68.4 percentage of patients
Interval 62.7 to 74.1
|
62.1 percentage of patients
Interval 56.2 to 68.1
|
61.3 percentage of patients
Interval 55.4 to 67.3
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
|
2.02 events per patient per month
Standard Error 0.15
|
1.32 events per patient per month
Standard Error 0.15
|
1.54 events per patient per month
Standard Error 0.15
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Percentage of Patients With at Least One Unexplained Hyperglycemia
|
61.3 percentage of patients
Interval 55.4 to 67.3
|
55.9 percentage of patients
Interval 49.8 to 61.9
|
56.3 percentage of patients
Interval 50.2 to 62.3
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Monthly Rate of Unexplained Hyperglycemia
|
1.61 events per patient per month
Standard Error 0.13
|
1.04 events per patient per month
Standard Error 0.13
|
1.23 events per patient per month
Standard Error 0.13
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Percentage of Patients With at Least One Confirmed Infusion Set Occlusion
|
32.8 percentage of patients
Interval 27.1 to 38.6
|
27.0 percentage of patients
Interval 21.5 to 32.4
|
27.0 percentage of patients
Interval 21.5 to 32.4
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Monthly Rate of Confirmed Infusion Set Occlusion
|
0.41 events per patient per month
Standard Error 0.06
|
0.28 events per patient per month
Standard Error 0.06
|
0.31 events per patient per month
Standard Error 0.06
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
|
17.6 percentage of patients
Interval 12.9 to 22.2
|
10.9 percentage of patients
Interval 7.1 to 14.8
|
11.7 percentage of patients
Interval 7.8 to 15.7
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis
|
0.14 events per patient per month
Standard Error 0.43
|
0.06 events per patient per month
Standard Error 0.22
|
0.06 events per patient per month
Standard Error 0.18
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year
|
73.88 events in patient-year
Standard Error 4.74
|
65.06 events in patient-year
Standard Error 4.74
|
62.74 events in patient-year
Standard Error 4.74
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Rate of Severe Symptomatic Hypoglycemia Per Patient-year
|
1.63 events in patient-year
Standard Error 0.35
|
1.39 events in patient-year
Standard Error 0.35
|
1.07 events in patient-year
Standard Error 0.35
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year
|
12.80 events in patient-year
Standard Error 0.95
|
9.66 events in patient-year
Standard Error 0.95
|
9.48 events in patient-year
Standard Error 0.95
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site
|
110 patients
|
110 patients
|
107 patients
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Time Interval Between Infusion Set Changes: All Changes
|
69.1 hours
Standard Deviation 20.70
|
69.44 hours
Standard Deviation 19.22
|
69.98 hours
Standard Deviation 21.64
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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.
Outcome measures
| Measure |
Insulin Glulisine
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=254 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Time Interval Between Infusion Set Changes in Routine
|
70.72 hours
Standard Deviation 21.47
|
71.00 hours
Standard Deviation 20.68
|
71.07 hours
Standard Deviation 21.65
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
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%
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Glycosylated Hemoglobin: HbA1c
First week (week 1) (n=253, n=254, n=255)
|
7.31 percentage
Standard Deviation 0.71
|
7.33 percentage
Standard Deviation 0.71
|
7.28 percentage
Standard Deviation 0.71
|
|
Glycosylated Hemoglobin: HbA1c
Last week (week 13) (n=252, n=255, n=251)
|
7.32 percentage
Standard Deviation 0.03
|
7.25 percentage
Standard Deviation 0.03
|
7.33 percentage
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
dose of the basal insulin regimen administered throughout the 24-hour period
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Total Daily Basal Insulin Infusion
Last week (week 13) (n=251, n=249, n=251)
|
20.86 Units
Standard Deviation 9.24
|
20.81 Units
Standard Deviation 9.73
|
21.11 Units
Standard Deviation 9.38
|
|
Total Daily Basal Insulin Infusion
First week (week 1) (n=251, n=249, n=250)
|
20.83 Units
Standard Deviation 9.05
|
20.93 Units
Standard Deviation 9.45
|
20.85 Units
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: over 13 weeks of each treatment periodPopulation: 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).
dose of every increment administered for example before meals
Outcome measures
| Measure |
Insulin Glulisine
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=256 Participants
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Total Daily Bolus Insulin Dose
First week (week 1) (n=249, n=247, n=250)
|
18.63 Units
Standard Deviation 9.22
|
18.49 Units
Standard Deviation 9.00
|
18.40 Units
Standard Deviation 8.69
|
|
Total Daily Bolus Insulin Dose
Last week (week 13) (n=248, n=244, n=249)
|
18.58 Units
Standard Deviation 8.49
|
18.64 Units
Standard Deviation 9.60
|
19.19 Units
Standard Deviation 9.13
|
Adverse Events
Insulin Glulisine
Serious events: 29 serious events
Other events: 47 other events
Deaths: 0 deaths
Insulin Aspart
Serious events: 18 serious events
Other events: 24 other events
Deaths: 0 deaths
Insulin Lispro
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glulisine
n=274 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=266 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=269 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Metabolism and nutrition disorders
hypoglycaemic seizure
|
2.9%
8/274 • 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.
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.
|
1.1%
3/266 • 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.
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.
|
1.5%
4/269 • 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.
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.
|
|
Metabolism and nutrition disorders
ketosis
|
3.3%
9/274 • 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.
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.
|
1.5%
4/266 • 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.
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.
|
0.74%
2/269 • 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.
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.
|
|
Metabolism and nutrition disorders
hypoglycaemic unconsciousness
|
1.5%
4/274 • 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.
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.
|
2.3%
6/266 • 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.
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.
|
0.74%
2/269 • 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.
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.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
1.1%
3/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Cardiac disorders
arteritis coronary
|
0.00%
0/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Cardiac disorders
cardiovascular disorders
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Cardiac disorders
coronary artery stenosis
|
0.00%
0/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Injury, poisoning and procedural complications
overdose
|
0.36%
1/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Injury, poisoning and procedural complications
forearm fracture
|
0.00%
0/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.37%
1/269 • 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.
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.
|
|
Nervous system disorders
headache
|
0.00%
0/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Nervous system disorders
hemianopia
|
0.00%
0/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.37%
1/269 • 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.
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.
|
|
Nervous system disorders
hypoglycaemic coma
|
0.00%
0/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
General disorders
chest pain
|
0.36%
1/274 • 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.
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.
|
0.38%
1/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.37%
1/269 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
|
Psychiatric disorders
depression
|
0.36%
1/274 • 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.
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.
|
0.00%
0/266 • 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.
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.
|
0.00%
0/269 • 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.
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.
|
Other adverse events
| Measure |
Insulin Glulisine
n=274 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Aspart
n=266 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Insulin Lispro
n=269 participants at risk
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Ketosis
|
17.2%
47/274 • 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.
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.
|
9.0%
24/266 • 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.
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.
|
11.2%
30/269 • 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.
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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER