Trial Outcomes & Findings for Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction (NCT NCT00670228)
NCT ID: NCT00670228
Last Updated: 2011-02-11
Results Overview
Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
From baseline at Day 60
Results posted on
2011-02-11
Participant Flow
Multicenter study: 60 out of the 90 centers planned were initiated. Only 17 centers randomized patients (i.e. 7 sites in the United States, 5 sites in Argentina, 3 sites in Brazil and 2 sites in Mexico).
Although 34 patients signed the informed consent form for study inclusion, one patient did not sign the Health Insurance Portability and Accountability Act (HIPAA) form, electing to keep his/her medical information private, and was therefore not randomized.
Participant milestones
| Measure |
Intensive Insulin Therapy (IIT)
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Intensive Insulin Therapy (IIT)
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death or MACE
|
0
|
1
|
|
Overall Study
Not treated
|
2
|
2
|
|
Overall Study
Not meeting the selection criteria
|
2
|
0
|
Baseline Characteristics
Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Intensive Insulin Therapy (IIT)
n=18 Participants
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=15 Participants
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.11 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
62.80 years
STANDARD_DEVIATION 11.12 • n=7 Participants
|
61.88 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.95 Kg/m^2
STANDARD_DEVIATION 3.34 • n=5 Participants
|
28.49 Kg/m^2
STANDARD_DEVIATION 3.92 • n=7 Participants
|
27.65 Kg/m^2
STANDARD_DEVIATION 3.64 • n=5 Participants
|
|
Diabetes diagnosis at study entry
Yes
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Diabetes diagnosis at study entry
No
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Duration of Diabetes at study entry
|
9.50 Years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
7.50 Years
STANDARD_DEVIATION 6.80 • n=7 Participants
|
8.50 Years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
|
Mean time to Percutaneous Coronary Intervention (PCI)
|
110.00 minutes
STANDARD_DEVIATION 112.69 • n=5 Participants
|
101.54 minutes
STANDARD_DEVIATION 51.47 • n=7 Participants
|
106.07 minutes
STANDARD_DEVIATION 88.21 • n=5 Participants
|
|
Myocardial Infarction (MI) duration greater than 3 hours
No
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Myocardial Infarction (MI) duration greater than 3 hours
Yes
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline at Day 60Population: Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.
Outcome measures
| Measure |
Intensive Insulin Therapy (IIT)
n=11 Participants
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=12 Participants
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Infarct Size Absolute Change From Baseline at Day 60
|
-7.84 percentage of LV mass change
Standard Deviation 9.19
|
-15.72 percentage of LV mass change
Standard Deviation 22.41
|
SECONDARY outcome
Timeframe: At Day 3Population: Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.
Outcome measures
| Measure |
Intensive Insulin Therapy (IIT)
n=11 Participants
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=12 Participants
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
|
43.08 percentage of Ejection Fraction
Standard Deviation 11.34
|
43.43 percentage of Ejection Fraction
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: At Day 60Population: Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.
MACE: Cardiac death, New onset or worsening congestive heart failure (\>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation
Outcome measures
| Measure |
Intensive Insulin Therapy (IIT)
n=16 Participants
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=13 Participants
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Severe arrhythmia
|
7 events
|
2 events
|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Shock
|
0 events
|
1 events
|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Revascularization
|
1 events
|
0 events
|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
New onset or worsening of congestive heart failure
|
1 events
|
0 events
|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Myocardial Infarction (MI)
|
1 events
|
0 events
|
|
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Death
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: At Day 60Population: Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Outcome measures
| Measure |
Intensive Insulin Therapy (IIT)
n=11 Participants
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=12 Participants
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
|
2.52 mg/L
Standard Deviation 2.10
|
2.96 mg/L
Standard Deviation 4.07
|
Adverse Events
Intensive Insulin Therapy (IIT)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Standard Glycemic Care (SGC)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Insulin Therapy (IIT)
n=16 participants at risk
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=13 participants at risk
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Cardiogenic Shock
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Pericardial Effusion
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Pericarditis
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
15.4%
2/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Infections and infestations
Bronchopneumonia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Psychiatric disorders
Psychotic Disorder
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Renal and urinary disorders
Renal Failure Acute
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
Other adverse events
| Measure |
Intensive Insulin Therapy (IIT)
n=16 participants at risk
In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
|
Standard Glycemic Care (SGC)
n=13 participants at risk
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Angina Pectoris
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Myocardial Infarction
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Myocardial Ischaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
15.4%
2/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Ventricular Fibrillation
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Cardiac disorders
Ventricular Tachycardia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
15.4%
2/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
15.4%
2/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Injection Site Phlebitis
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Venipuncture Site Swelling
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Vessel Puncture Site Haematoma
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Vessel Site Puncture Haemorrhage
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Investigations
Blood Magnesium Decreased
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Investigations
Transaminases Increased
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Psychiatric disorders
Confusional State
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
2/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Renal and urinary disorders
Renal Failure
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
7.7%
1/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Skin and subcutaneous tissue disorders
Petechia
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
|
Vascular disorders
Hypotension
|
25.0%
4/16 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
0.00%
0/13 • Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
|
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