Trial Outcomes & Findings for Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension (NCT NCT00881530)
NCT ID: NCT00881530
Last Updated: 2014-06-16
Results Overview
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
660 participants
Primary outcome timeframe
78 weeks plus 1 week of follow-up
Results posted on
2014-06-16
Participant Flow
This was an open label extension trial of the blinded 12-week dose-finding studies NCT00789035 and NCT00749190.
Patients from the preceding empagliflozin 10 and 25 mg groups continued to take the same doses. Patients on placebo and other empagliflozin doses were re-randomised to one of the empagliflozin treatments. Patients on metformin monotherapy or sitagliptin added-on to metformin in the preceding trials continued their open label treatments.
Participant milestones
| Measure |
Empagliflozin 10 mg
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
109
|
56
|
166
|
166
|
56
|
|
Overall Study
COMPLETED
|
92
|
104
|
51
|
157
|
152
|
51
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
5
|
9
|
14
|
5
|
Reasons for withdrawal
| Measure |
Empagliflozin 10 mg
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
1
|
4
|
10
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Not compliant with the protocol
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
3
|
1
|
0
|
|
Overall Study
Refused to continue medication
|
7
|
2
|
1
|
2
|
0
|
0
|
|
Overall Study
Other reason not defined above
|
1
|
1
|
2
|
0
|
0
|
2
|
Baseline Characteristics
Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Baseline characteristics by cohort
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Total
n=659 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
58.3 years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
58.6 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
325 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
334 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 78 weeks plus 1 week of follow-upPopulation: Treated set
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Hypoglycaemic Events
|
0.9 percentage of participants
|
1.8 percentage of participants
|
7.1 percentage of participants
|
2.4 percentage of participants
|
3.6 percentage of participants
|
5.4 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 78Population: Treated set
Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Outcome measures
| Measure |
Empagliflozin 10 mg
n=105 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=164 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=162 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 78 in Lipid Parameters
Total Cholesterol
|
-0.13 mmol/L
Standard Deviation 1.17
|
0.09 mmol/L
Standard Deviation 0.88
|
-0.24 mmol/L
Standard Deviation 0.77
|
0.19 mmol/L
Standard Deviation 0.81
|
0.13 mmol/L
Standard Deviation 0.75
|
-0.05 mmol/L
Standard Deviation 0.91
|
|
Change From Baseline to Week 78 in Lipid Parameters
HDL
|
0.08 mmol/L
Standard Deviation 0.11
|
0.07 mmol/L
Standard Deviation 0.10
|
0.06 mmol/L
Standard Deviation 0.10
|
0.06 mmol/L
Standard Deviation 0.09
|
0.07 mmol/L
Standard Deviation 0.10
|
0.03 mmol/L
Standard Deviation 0.08
|
|
Change From Baseline to Week 78 in Lipid Parameters
LDL (N=102, 108, 52, 161, 159, 55)
|
-0.02 mmol/L
Standard Deviation 0.83
|
0.05 mmol/L
Standard Deviation 0.83
|
-0.13 mmol/L
Standard Deviation 0.74
|
0.13 mmol/L
Standard Deviation 0.71
|
0.07 mmol/L
Standard Deviation 0.69
|
0.00 mmol/L
Standard Deviation 0.79
|
|
Change From Baseline to Week 78 in Lipid Parameters
Triglyceride
|
-0.5 mmol/L
Standard Deviation 2.3
|
-0.0 mmol/L
Standard Deviation 0.6
|
-0.5 mmol/L
Standard Deviation 1.2
|
0.1 mmol/L
Standard Deviation 0.9
|
-0.1 mmol/L
Standard Deviation 0.8
|
-0.2 mmol/L
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 78 weeks plus 1 week of follow-upPopulation: Treated set
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Tachycardia
|
0.9 percentage of participants
|
1.8 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Alanine aminotransferase increased
|
0.9 percentage of participants
|
0.9 percentage of participants
|
3.6 percentage of participants
|
0.6 percentage of participants
|
0.6 percentage of participants
|
1.8 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Aspartate aminotransferase increased
|
1.9 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Gamma-glutamyltransferase increased
|
0.9 percentage of participants
|
0.0 percentage of participants
|
1.8 percentage of participants
|
0.0 percentage of participants
|
1.2 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Blood alkaline phosphatase increased
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Blood creatine phosphokinase increased
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Granulocyte count decreased
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Hepatic enzyme increased
|
0.0 percentage of participants
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Blood creatinine increased
|
0.9 percentage of participants
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Creatinine renal clearance decreased
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Weight decreased
|
0.0 percentage of participants
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Sick sinus syndrome
|
0.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 6, 18, 30, 42, 54, 66 and 78Population: Treated set
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c Over Time
Week 54 (N=78, 85, 44, 128, 136, 41)
|
-0.66 percentage of HbA1c
Standard Deviation 0.83
|
-0.71 percentage of HbA1c
Standard Deviation 0.87
|
-1.13 percentage of HbA1c
Standard Deviation 0.89
|
-0.62 percentage of HbA1c
Standard Deviation 0.76
|
-0.75 percentage of HbA1c
Standard Deviation 0.73
|
-0.79 percentage of HbA1c
Standard Deviation 0.79
|
|
Change From Baseline in HbA1c Over Time
Week 6 (N=104, 108, 55, 162, 163, 54)
|
-0.40 percentage of HbA1c
Standard Deviation 0.77
|
-0.57 percentage of HbA1c
Standard Deviation 0.81
|
-1.03 percentage of HbA1c
Standard Deviation 0.76
|
-0.36 percentage of HbA1c
Standard Deviation 0.67
|
-0.55 percentage of HbA1c
Standard Deviation 0.60
|
-0.75 percentage of HbA1c
Standard Deviation 0.80
|
|
Change From Baseline in HbA1c Over Time
Week 18 (N=93, 105, 53, 149, 157, 48)
|
-0.58 percentage of HbA1c
Standard Deviation 0.75
|
-0.72 percentage of HbA1c
Standard Deviation 0.88
|
-0.92 percentage of HbA1c
Standard Deviation 0.91
|
-0.51 percentage of HbA1c
Standard Deviation 0.68
|
-0.70 percentage of HbA1c
Standard Deviation 0.68
|
-0.79 percentage of HbA1c
Standard Deviation 0.84
|
|
Change From Baseline in HbA1c Over Time
Week 30 (N=93, 99, 50, 140, 151, 45)
|
-0.47 percentage of HbA1c
Standard Deviation 0.85
|
-0.61 percentage of HbA1c
Standard Deviation 0.90
|
-0.95 percentage of HbA1c
Standard Deviation 0.82
|
-0.58 percentage of HbA1c
Standard Deviation 0.69
|
-0.76 percentage of HbA1c
Standard Deviation 0.70
|
-0.68 percentage of HbA1c
Standard Deviation 0.82
|
|
Change From Baseline in HbA1c Over Time
Week 42 (N=85, 93, 46, 132, 140, 44)
|
-0.59 percentage of HbA1c
Standard Deviation 0.87
|
-0.74 percentage of HbA1c
Standard Deviation 0.98
|
-1.10 percentage of HbA1c
Standard Deviation 0.80
|
-0.65 percentage of HbA1c
Standard Deviation 0.72
|
-0.79 percentage of HbA1c
Standard Deviation 0.76
|
-0.51 percentage of HbA1c
Standard Deviation 1.03
|
|
Change From Baseline in HbA1c Over Time
Week 66 (N=80, 87, 43, 120, 127, 39)
|
-0.55 percentage of HbA1c
Standard Deviation 0.80
|
-0.71 percentage of HbA1c
Standard Deviation 1.01
|
-1.04 percentage of HbA1c
Standard Deviation 0.79
|
-0.59 percentage of HbA1c
Standard Deviation 0.79
|
-0.73 percentage of HbA1c
Standard Deviation 0.77
|
-0.78 percentage of HbA1c
Standard Deviation 0.90
|
|
Change From Baseline in HbA1c Over Time
Week 78 (N=72, 84, 42, 115, 121, 38)
|
-0.50 percentage of HbA1c
Standard Deviation 0.77
|
-0.55 percentage of HbA1c
Standard Deviation 0.90
|
-0.80 percentage of HbA1c
Standard Deviation 0.88
|
-0.56 percentage of HbA1c
Standard Deviation 0.80
|
-0.71 percentage of HbA1c
Standard Deviation 0.81
|
-0.66 percentage of HbA1c
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Weeks 1, 6, 18, 30, 42, 54, 66 and 78Population: Treated set
Occurence of a treat-to-target response, defined as HbA1c \< 7.0% over time
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 6 (N=104, 108, 55, 162, 163, 54)
|
26.9 percentage of participants
|
25.0 percentage of participants
|
45.5 percentage of participants
|
24.1 percentage of participants
|
25.2 percentage of participants
|
35.2 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 18 (N=93, 105, 53, 149, 157, 48)
|
33.3 percentage of participants
|
33.3 percentage of participants
|
45.3 percentage of participants
|
31.5 percentage of participants
|
37.6 percentage of participants
|
35.4 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 30 (N=93, 99, 50, 140, 151, 45)
|
34.4 percentage of participants
|
29.3 percentage of participants
|
42.0 percentage of participants
|
28.6 percentage of participants
|
45.7 percentage of participants
|
28.9 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 42 (N=85, 93, 46, 132, 140, 44)
|
41.2 percentage of participants
|
40.9 percentage of participants
|
52.2 percentage of participants
|
39.4 percentage of participants
|
47.1 percentage of participants
|
25.0 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 54 (N=78, 85, 44, 128, 136, 41)
|
43.6 percentage of participants
|
32.9 percentage of participants
|
56.8 percentage of participants
|
35.9 percentage of participants
|
47.8 percentage of participants
|
29.3 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 66 (N=80, 87, 43, 120, 127, 39)
|
31.3 percentage of participants
|
39.1 percentage of participants
|
44.2 percentage of participants
|
35.8 percentage of participants
|
48.0 percentage of participants
|
38.5 percentage of participants
|
|
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Week 78 (N=72, 84, 42, 115, 121, 38)
|
31.9 percentage of participants
|
32.1 percentage of participants
|
31.0 percentage of participants
|
27.0 percentage of participants
|
44.6 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 6, 18, 30, 42, 54, 66 and 78Population: Treated set
Occurrence of a Treat-to-target Response, defined as HbA1c \< 6.5% over time
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 6 (N=104, 108, 55, 162, 163, 54)
|
3.8 percentage of participants
|
11.1 percentage of participants
|
16.4 percentage of participants
|
6.2 percentage of participants
|
6.7 percentage of participants
|
11.1 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 18 (N=93, 105, 53, 149, 157, 48)
|
11.8 percentage of participants
|
12.4 percentage of participants
|
13.2 percentage of participants
|
4.7 percentage of participants
|
5.1 percentage of participants
|
12.5 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 30 (N=93, 99, 50, 140, 151, 45)
|
8.6 percentage of participants
|
10.1 percentage of participants
|
14.0 percentage of participants
|
8.6 percentage of participants
|
10.6 percentage of participants
|
4.4 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 42 (N=85, 93, 46, 132, 140, 44)
|
11.8 percentage of participants
|
10.8 percentage of participants
|
21.7 percentage of participants
|
10.6 percentage of participants
|
21.4 percentage of participants
|
9.1 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 54 (N=78, 85, 44, 128, 136, 41)
|
11.5 percentage of participants
|
5.9 percentage of participants
|
18.2 percentage of participants
|
10.9 percentage of participants
|
15.4 percentage of participants
|
9.8 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 66 (N=80, 87, 43, 120, 127, 39)
|
10.0 percentage of participants
|
11.5 percentage of participants
|
14.0 percentage of participants
|
8.3 percentage of participants
|
12.6 percentage of participants
|
15.4 percentage of participants
|
|
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Week 78 (N=72, 84, 42, 115, 121, 38)
|
6.9 percentage of participants
|
8.3 percentage of participants
|
9.5 percentage of participants
|
10.4 percentage of participants
|
13.2 percentage of participants
|
18.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 6, 18, 30, 42, 54, 66 and 78Population: Treated set
Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least \>=0.5% over time)
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Occurrence of a Relative Efficacy Response
Week 6 (N=104, 108, 55, 162, 163, 54)
|
42.3 percentage of participants
|
50.9 percentage of participants
|
80.0 percentage of participants
|
41.4 percentage of participants
|
56.4 percentage of participants
|
63.0 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 18 (N=93, 105, 53, 149, 157, 48)
|
51.6 percentage of participants
|
61.9 percentage of participants
|
77.4 percentage of participants
|
53.7 percentage of participants
|
61.8 percentage of participants
|
66.7 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 30 (N=93, 99, 50, 140, 151, 45)
|
50.5 percentage of participants
|
55.6 percentage of participants
|
78.0 percentage of participants
|
55.0 percentage of participants
|
63.6 percentage of participants
|
68.9 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 42 (N=85, 93, 46, 132, 140, 44)
|
58.8 percentage of participants
|
60.2 percentage of participants
|
82.6 percentage of participants
|
62.1 percentage of participants
|
66.4 percentage of participants
|
54.5 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 54 (N=78, 85, 44, 128, 136, 41)
|
62.8 percentage of participants
|
58.8 percentage of participants
|
81.8 percentage of participants
|
59.4 percentage of participants
|
65.4 percentage of participants
|
58.5 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 66 (N=80, 87, 43, 120, 127, 39)
|
53.8 percentage of participants
|
56.3 percentage of participants
|
76.7 percentage of participants
|
55.0 percentage of participants
|
64.6 percentage of participants
|
66.7 percentage of participants
|
|
Occurrence of a Relative Efficacy Response
Week 78 (N=72, 84, 42, 115, 121, 38)
|
50.0 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
56.5 percentage of participants
|
64.5 percentage of participants
|
60.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 6, 18, 30, 42, 54, 66 and 78Population: Treated set
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Outcome measures
| Measure |
Empagliflozin 10 mg
n=106 Participants
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 Participants
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 Participants
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 Participants
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 Participants
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 Participants
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 6 (N=102, 108, 55, 156, 160, 53)
|
-30.6 mg/dL
Standard Deviation 42.5
|
-35.8 mg/dL
Standard Deviation 39.6
|
-29.9 mg/dL
Standard Deviation 40.0
|
-25.7 mg/dL
Standard Deviation 35.2
|
-36.7 mg/dL
Standard Deviation 36.3
|
-32.6 mg/dL
Standard Deviation 42.4
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 18 (N=94, 103, 51, 144, 153, 45)
|
-35.5 mg/dL
Standard Deviation 37.9
|
-33.7 mg/dL
Standard Deviation 42.0
|
-30.4 mg/dL
Standard Deviation 40.3
|
-30.6 mg/dL
Standard Deviation 31.6
|
-37.6 mg/dL
Standard Deviation 35.8
|
-16.7 mg/dL
Standard Deviation 44.0
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 30 (N=92, 101, 51, 133, 147, 43)
|
-32.3 mg/dL
Standard Deviation 41.4
|
-35.0 mg/dL
Standard Deviation 39.6
|
-28.5 mg/dL
Standard Deviation 28.9
|
-29.9 mg/dL
Standard Deviation 34.9
|
-37.9 mg/dL
Standard Deviation 38.6
|
-25.6 mg/dL
Standard Deviation 38.6
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 42 (N=85, 93, 46, 126, 140, 42)
|
-35.8 mg/dL
Standard Deviation 39.1
|
-31.3 mg/dL
Standard Deviation 41.4
|
-31.0 mg/dL
Standard Deviation 35.6
|
-30.8 mg/dL
Standard Deviation 36.4
|
-36.8 mg/dL
Standard Deviation 34.1
|
-18.5 mg/dL
Standard Deviation 43.1
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 54 (N=80, 88, 44, 124, 134, 39)
|
-32.1 mg/dL
Standard Deviation 37.2
|
-31.0 mg/dL
Standard Deviation 37.8
|
-31.8 mg/dL
Standard Deviation 35.9
|
-28.2 mg/dL
Standard Deviation 33.7
|
-36.8 mg/dL
Standard Deviation 32.5
|
-29.4 mg/dL
Standard Deviation 35.4
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 66 (N=80, 86, 43, 116, 125, 38)
|
-28.0 mg/dL
Standard Deviation 41.4
|
-28.6 mg/dL
Standard Deviation 42.6
|
-26.4 mg/dL
Standard Deviation 35.7
|
-21.7 mg/dL
Standard Deviation 36.2
|
-29.6 mg/dL
Standard Deviation 36.4
|
-32.5 mg/dL
Standard Deviation 46.9
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Week 78 (N=72, 84, 43, 112, 121, 36)
|
-27.9 mg/dL
Standard Deviation 33.1
|
-25.4 mg/dL
Standard Deviation 40.9
|
-22.9 mg/dL
Standard Deviation 39.7
|
-24.7 mg/dL
Standard Deviation 41.5
|
-31.9 mg/dL
Standard Deviation 36.5
|
-25.7 mg/dL
Standard Deviation 48.9
|
Adverse Events
Empagliflozin 10 mg
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Empagliflozin 25 mg
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Metformin
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Empagliflozin 10 mg + Metformin
Serious events: 10 serious events
Other events: 74 other events
Deaths: 0 deaths
Empagliflozin 25 mg + Metformin
Serious events: 13 serious events
Other events: 79 other events
Deaths: 0 deaths
Sitaglipin + Metformin
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empagliflozin 10 mg
n=106 participants at risk
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 participants at risk
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 participants at risk
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 participants at risk
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 participants at risk
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 participants at risk
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Gingival cyst
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
2/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Anal abscess
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma recurrent
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with multilineage dysplasia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Endocrine disorders
Goitre
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
2/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
2/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Aphasia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.2%
2/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Eye disorders
Visual acuity reduced
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Vascular disorders
Hypertension
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.9%
2/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
General disorders
Death
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
General disorders
Pyrexia
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
Other adverse events
| Measure |
Empagliflozin 10 mg
n=106 participants at risk
Patients receive 10 mg Empagliflozin in tablets once daily.
|
Empagliflozin 25 mg
n=109 participants at risk
Patients receive 25 mg Empagliflozin in tablets once daily.
|
Metformin
n=56 participants at risk
Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
|
Empagliflozin 10 mg + Metformin
n=166 participants at risk
Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Empagliflozin 25 mg + Metformin
n=166 participants at risk
Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
Sitaglipin + Metformin
n=56 participants at risk
Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.4%
10/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.3%
8/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
16.1%
9/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.2%
12/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
9.0%
15/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
8.9%
5/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Urinary tract infection
|
2.8%
3/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.7%
4/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.2%
12/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
10.8%
18/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
8.9%
5/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Bronchitis
|
1.9%
2/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.8%
3/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
2/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.2%
2/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
4.8%
8/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
10.7%
6/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
5/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.3%
8/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
3/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.2%
2/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Infections and infestations
Viral infection
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
6.4%
7/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.3%
12/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
14.7%
16/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
14.3%
8/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
21.7%
36/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
15.1%
25/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
16.1%
9/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
2/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.1%
4/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.4%
4/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
6/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
6.4%
7/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.1%
4/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
6/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
4.2%
7/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Vascular disorders
Hypertension
|
3.8%
4/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.8%
3/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.1%
4/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.0%
5/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.2%
2/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.1%
4/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
2/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
6/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
3.6%
6/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
7.1%
4/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.8%
3/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
3/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.4%
4/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.94%
1/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
2.8%
3/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
General disorders
Chest pain
|
1.9%
2/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.2%
2/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.00%
0/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
|
General disorders
Fatigue
|
0.00%
0/106 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.92%
1/109 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
1.8%
1/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
0.60%
1/166 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
5.4%
3/56 • From drug administration until 7 days after the last intake of study drug, up to 582 days
|
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