Trial Outcomes & Findings for A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate (NCT NCT00740051)
NCT ID: NCT00740051
Last Updated: 2014-06-27
Results Overview
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
227 participants
Primary outcome timeframe
Baseline and week 18
Results posted on
2014-06-27
Participant Flow
Participant milestones
| Measure |
Placebo/Glimepiride
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
151
|
|
Overall Study
COMPLETED
|
58
|
119
|
|
Overall Study
NOT COMPLETED
|
18
|
32
|
Reasons for withdrawal
| Measure |
Placebo/Glimepiride
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
5
|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Protocol Violation
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Other reason (not specified)
|
4
|
1
|
Baseline Characteristics
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Baseline characteristics by cohort
| Measure |
Placebo/Glimepiride
n=76 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=151 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
56.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Body Mass Index (BMI) continuous
|
30.19 kg/m^2
STANDARD_DEVIATION 4.97 • n=5 Participants
|
29.09 kg/m^2
STANDARD_DEVIATION 5.62 • n=7 Participants
|
29.46 kg/m^2
STANDARD_DEVIATION 5.42 • n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c) - Interim Analysis
|
8.06 percent
STANDARD_DEVIATION 0.89 • n=5 Participants
|
8.11 percent
STANDARD_DEVIATION 0.95 • n=7 Participants
|
8.09 percent
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Fasting blood plasma (FPG) glucose
|
180.5 mg/dL
STANDARD_DEVIATION 44.7 • n=5 Participants
|
183.3 mg/dL
STANDARD_DEVIATION 46.4 • n=7 Participants
|
182.4 mg/dL
STANDARD_DEVIATION 45.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 18Population: The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Outcome measures
| Measure |
Placebo
n=73 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=147 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
HbA1c Change From Baseline at Week 18 (Interim Analysis)
|
0.14 percent
Standard Error 0.16
|
-0.44 percent
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Baseline and week 18Population: The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.
Outcome measures
| Measure |
Placebo
n=73 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=147 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
HbA1c Change From Baseline at Week 18 (Final Analysis)
|
0.21 percent
Standard Error 0.16
|
-0.39 percent
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and week 18Population: All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).
This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).
Outcome measures
| Measure |
Placebo
n=66 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=138 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)
|
7.2 mg/dl
Standard Error 6.0
|
-13.3 mg/dl
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Week 18Population: Full Analysis Set (FAS) patients with baseline HbA1c \>= 7.0%. Patients without a value at week 18 were analysed as non-responders.
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Outcome measures
| Measure |
Placebo
n=68 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=136 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)
|
11.8 percent of patients
|
23.5 percent of patients
|
SECONDARY outcome
Timeframe: Week 18Population: FAS patients with baseline HbA1c \>= 6.5%. Patients without a value at Week 18 were analysed as non-responders.
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Outcome measures
| Measure |
Placebo
n=70 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=146 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)
|
2.9 percent of patients
|
8.9 percent of patients
|
SECONDARY outcome
Timeframe: Week 18Population: The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Outcome measures
| Measure |
Placebo
n=73 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=147 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)
|
17.8 percent of patients
|
36.1 percent of patients
|
SECONDARY outcome
Timeframe: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52Population: Treated set (OC)
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Placebo
n=76 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=151 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 6 (N=64, 136)
|
0.26 percent
Standard Deviation 0.98
|
-0.21 percent
Standard Deviation 0.77
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 12 (N=57, 129)
|
0.26 percent
Standard Deviation 1.08
|
-0.43 percent
Standard Deviation 0.84
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 18 (N=47, 118)
|
0.10 percent
Standard Deviation 1.06
|
-0.38 percent
Standard Deviation 0.87
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 22 (N=46, 113)
|
-0.32 percent
Standard Deviation 0.82
|
-0.40 percent
Standard Deviation 0.94
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 26 (N=50, 110)
|
-0.53 percent
Standard Deviation 0.93
|
-0.48 percent
Standard Deviation 0.92
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 30 (N=49, 98)
|
-0.79 percent
Standard Deviation 1.06
|
-0.49 percent
Standard Deviation 0.92
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 34 (N=50, 96)
|
-0.75 percent
Standard Deviation 0.95
|
-0.49 percent
Standard Deviation 0.88
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 40 (N=49, 94)
|
-0.73 percent
Standard Deviation 1.11
|
-0.45 percent
Standard Deviation 0.90
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 46 (N=45, 92)
|
-0.78 percent
Standard Deviation 1.04
|
-0.42 percent
Standard Deviation 0.96
|
|
The Change in HbA1c From Baseline by Visit Over Time
Change from baseline at week 52 (N=45, 92)
|
-0.72 percent
Standard Deviation 1.01
|
-0.44 percent
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52Population: Treated set (OC)
This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.
Outcome measures
| Measure |
Placebo
n=76 Participants
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=151 Participants
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 6 (N=63, 134)
|
9.7 mg/dL
Standard Deviation 30.7
|
-8.4 mg/dL
Standard Deviation 41.0
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 12 (N=55,92)
|
5.4 mg/dL
Standard Deviation 33.0
|
-14.3 mg/dL
Standard Deviation 37.3
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 18 (N=47, 115)
|
5.0 mg/dL
Standard Deviation 32.4
|
-12.9 mg/dL
Standard Deviation 35.9
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 22 (N=46, 110)
|
-19.3 mg/dL
Standard Deviation 33.3
|
-14.0 mg/dL
Standard Deviation 41.8
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 26 (N=50, 108)
|
-22.6 mg/dL
Standard Deviation 33.8
|
-17.0 mg/dL
Standard Deviation 37.8
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 30 (N=48, 95)
|
-31.4 mg/dL
Standard Deviation 29.5
|
-19.1 mg/dL
Standard Deviation 39.1
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 34 (N=48, 95)
|
-25.6 mg/dL
Standard Deviation 35.2
|
-15.8 mg/dL
Standard Deviation 36.0
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 40 (N=47, 92)
|
-19.5 mg/dL
Standard Deviation 33.2
|
-19.0 mg/dL
Standard Deviation 36.9
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 46 (N=47, 92)
|
-22.8 mg/dL
Standard Deviation 32.3
|
-18.1 mg/dL
Standard Deviation 38.8
|
|
The Change in FPG From Baseline by Visit Over Time
Change from baseline at week 52 (N=43, 86)
|
-19.1 mg/dL
Standard Deviation 30.1
|
-14.0 mg/dL
Standard Deviation 37.1
|
Adverse Events
Placebo/Glimepiride
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Linagliptin
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Glimepiride
n=76 participants at risk
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=151 participants at risk
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
0.00%
0/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
0.66%
1/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
0.00%
0/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
1/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
0.00%
0/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
Other adverse events
| Measure |
Placebo/Glimepiride
n=76 participants at risk
Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
|
Linagliptin
n=151 participants at risk
Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
4/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
2.0%
3/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
General disorders
Fatigue
|
6.6%
5/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
1.3%
2/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Infections and infestations
Influenza
|
2.6%
2/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
5.3%
8/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
6/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
9.9%
15/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
7/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
4.0%
6/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.4%
14/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
14.6%
22/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
4/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
3.3%
5/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
4/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
4.0%
6/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Nervous system disorders
Dizziness
|
5.3%
4/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
7.3%
11/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Nervous system disorders
Headache
|
7.9%
6/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
5.3%
8/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
|
Psychiatric disorders
Anxiety
|
5.3%
4/76 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
0.00%
0/151 • 52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
|
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 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