Trial Outcomes & Findings for Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive (NCT NCT00800683)
NCT ID: NCT00800683
Last Updated: 2014-05-20
Results Overview
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
133 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2014-05-20
Participant Flow
Participant milestones
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
68
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=68 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
64.0 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
64.4 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Glycosylated haemoglobin (HbA1c) at baseline
|
8.2 percentage
STANDARD_DEVIATION 0.9 • n=93 Participants
|
8.2 percentage
STANDARD_DEVIATION 1.1 • n=4 Participants
|
8.2 percentage
STANDARD_DEVIATION 1.0 • n=27 Participants
|
|
Fasting plasma glucose (FPG) at baseline
|
160.1 mg/dL
STANDARD_DEVIATION 65.4 • n=93 Participants
|
149.5 mg/dL
STANDARD_DEVIATION 79.5 • n=4 Participants
|
154.6 mg/dL
STANDARD_DEVIATION 72.9 • n=27 Participants
|
|
Body Mass Index (BMI) Continuous
|
31.7 kg/m²
STANDARD_DEVIATION 5.9 • n=93 Participants
|
32.3 kg/m²
STANDARD_DEVIATION 5.9 • n=4 Participants
|
32.0 kg/m²
STANDARD_DEVIATION 5.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 12
|
-0.15 Percent
Standard Error 0.15
|
-0.76 Percent
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 52
|
0.01 Percent
Standard Error 0.16
|
-0.71 Percent
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 18
|
0.04 Percent
Standard Error 0.14
|
-0.57 Percent
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 24
|
0.04 Percent
Standard Error 0.14
|
-0.64 Percent
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 30
|
0.04 Percent
Standard Error 0.16
|
-0.67 Percent
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 36
|
0.03 Percent
Standard Error 0.16
|
-0.72 Percent
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and Week 42Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 42
|
-0.08 Percent
Standard Error 0.16
|
-0.73 Percent
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline at Week 48
|
-0.04 Percent
Standard Error 0.15
|
-0.77 Percent
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This population includes the FAS with baseline HbA1c\>=6.5%. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5%
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
|
0 Percentage of patients
|
6.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This population includes the FAS with baseline HbA1c\>=7.0%. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%.
Outcome measures
| Measure |
Placebo
n=61 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=61 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
|
9.8 Percentage of patients
|
18.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Outcome measures
| Measure |
Placebo
n=62 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
|
11.3 Percentage of patients
|
27.3 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 12
|
-7.08 mg/dL
Standard Error 11.08
|
-8.81 mg/dL
Standard Error 10.66
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 18
|
-12.72 mg/dL
Standard Error 7.94
|
-14.97 mg/dL
Standard Error 7.64
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 24
|
-6.22 mg/dL
Standard Error 7.84
|
-16.93 mg/dL
Standard Error 7.54
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 30
|
-14.54 mg/dL
Standard Error 7.68
|
-10.12 mg/dL
Standard Error 7.39
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 36
|
-11.29 mg/dL
Standard Error 8.53
|
-20.53 mg/dL
Standard Error 8.20
|
SECONDARY outcome
Timeframe: Baseline and Week 42Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 42
|
-13.25 mg/dL
Standard Error 8.02
|
-8.88 mg/dL
Standard Error 7.71
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at Week 48
|
-10.52 mg/dL
Standard Error 8.26
|
-3.45 mg/dL
Standard Error 7.95
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Outcome measures
| Measure |
Placebo
n=57 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=63 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
FPG Change From Baseline at week52
|
-6.81 mg/dL
Standard Error 7.92
|
-5.47 mg/dL
Standard Error 7.62
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Treated Set
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Outcome measures
| Measure |
Placebo
n=65 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=68 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Overall (Baseline -Week 52)
|
33 Participants
|
32 Participants
|
|
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Week 1- Week12
|
11 Participants
|
17 Participants
|
|
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Week 12 - Week 52
|
29 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: first administration of randomised treatment to ....Population: Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Outcome measures
| Measure |
Placebo
n=65 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=68 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Cardiac disorders - Tachycardia
|
1 participants
|
0 participants
|
|
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood amylase increased
|
1 participants
|
0 participants
|
|
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood creatine phosphokinase MB increased
|
1 participants
|
1 participants
|
|
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Blood creatine phosphokinase increased
|
1 participants
|
2 participants
|
|
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Glycosylated haemoglobin increased
|
0 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 27 serious events
Other events: 50 other events
Deaths: 0 deaths
Linagliptin (BI 1356)
Serious events: 25 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=68 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Angina pectoris
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Angina unstable
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Arrhythmia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Endocrine disorders
Parathyroid gland enlargement
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Cardiac disorders
Cardiac death
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
General disorders
Death
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
General disorders
Pyrexia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Device related sepsis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Gangrene
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Lobar pneumonia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Septic shock
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Investigations
Occult blood positive
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Nervous system disorders
Syncope
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Renal failure acute
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
7.4%
5/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilar enlargement
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
1.5%
1/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Vascular disorders
Peripheral ischaemia
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
0.00%
0/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
Patients randomized to receive treatment with matching placebo
|
Linagliptin (BI 1356)
n=68 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
4/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Constipation
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
11.8%
8/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
6/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
14.7%
10/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
7.4%
5/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
General disorders
Oedema peripheral
|
10.8%
7/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
10.3%
7/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
5.9%
4/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Influenza
|
1.5%
1/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
5.9%
4/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
8.8%
6/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
7/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
7.4%
5/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Infections and infestations
Urinary tract infection
|
10.8%
7/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
7.4%
5/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
4/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.8%
7/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
10.3%
7/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
35.4%
23/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
27.9%
19/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
21.5%
14/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
30.9%
21/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
49.2%
32/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
63.2%
43/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
5.9%
4/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
5/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
5.9%
4/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
7.4%
5/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
3/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
5.9%
4/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Nervous system disorders
Headache
|
6.2%
4/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
2.9%
2/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
3.1%
2/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
11.8%
8/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
5/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
6/65 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
4.4%
3/68 • 52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER