Trial Outcomes & Findings for Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes (NCT NCT01719003)
NCT ID: NCT01719003
Last Updated: 2016-02-19
Results Overview
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1413 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2016-02-19
Participant Flow
With the first global protocol amendment (13-Dec-2012), the HbA1c inclusion criterion changed and further enrolment in the open label (OL) group was stopped, but the patients already entered in the OL group could continue until the scheduled end of the study.
Patients with an (Glycosylated Haemoglobin) HbA1c \>10.0% at screening and meeting all other inclusion criteria were initially directly included in an OL treatment group
Participant milestones
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
Oral administration of Metformin 500 mg bid
|
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
170
|
170
|
171
|
169
|
167
|
172
|
170
|
171
|
53
|
|
Overall Study
COMPLETED
|
161
|
153
|
154
|
156
|
150
|
160
|
150
|
151
|
49
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
17
|
13
|
17
|
12
|
20
|
20
|
4
|
Reasons for withdrawal
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
Oral administration of Metformin 500 mg bid
|
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Non compliant with protocol
|
1
|
1
|
0
|
1
|
2
|
1
|
2
|
3
|
0
|
|
Overall Study
Adverse Event
|
6
|
5
|
4
|
3
|
4
|
3
|
6
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
7
|
2
|
3
|
4
|
3
|
2
|
2
|
|
Overall Study
Refusal to continue, not due to AE
|
2
|
5
|
4
|
4
|
4
|
3
|
8
|
7
|
1
|
|
Overall Study
Reason other than those specified
|
0
|
0
|
2
|
3
|
4
|
1
|
0
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=169 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=165 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=167 Participants
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=161 Participants
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=164 Participants
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=169 Participants
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=164 Participants
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=168 Participants
Oral administration of Metformin 500 mg bid
|
Total
n=1327 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
53.1 years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
51.6 years
STANDARD_DEVIATION 10.8 • n=8 Participants
|
53.4 years
STANDARD_DEVIATION 10.9 • n=24 Participants
|
52.6 years
STANDARD_DEVIATION 10.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
82 Participants
n=24 Participants
|
580 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
92 Participants
n=8 Participants
|
86 Participants
n=24 Participants
|
747 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksPopulation: FAS observed cases (OC) (Only patients with available data are analysed)
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Outcome measures
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=159 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=149 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=151 Participants
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=153 Participants
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=143 Participants
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=156 Participants
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=146 Participants
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=142 Participants
Oral administration of Metformin 500 mg bid
|
|---|---|---|---|---|---|---|---|---|
|
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
|
-2.08 percentage of HbA1c
Standard Error 0.08
|
-1.93 percentage of HbA1c
Standard Error 0.08
|
-2.07 percentage of HbA1c
Standard Error 0.08
|
-1.98 percentage of HbA1c
Standard Error 0.08
|
-1.36 percentage of HbA1c
Standard Error 0.08
|
-1.35 percentage of HbA1c
Standard Error 0.08
|
-1.75 percentage of HbA1c
Standard Error 0.09
|
-1.18 percentage of HbA1c
Standard Error 0.08
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: FAS observed cases (OC) (Only patients with available data are analysed)
Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
Outcome measures
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=158 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=146 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=146 Participants
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=153 Participants
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=139 Participants
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=154 Participants
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=145 Participants
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=139 Participants
Oral administration of Metformin 500 mg bid
|
|---|---|---|---|---|---|---|---|---|
|
FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
|
-51.0 mg/dL
Standard Error 2.4
|
-44.0 mg/dL
Standard Error 2.4
|
-47.8 mg/dL
Standard Error 2.4
|
-45.5 mg/dL
Standard Error 2.4
|
-28.0 mg/dL
Standard Error 2.5
|
-32.9 mg/dL
Standard Error 2.4
|
-32.1 mg/dL
Standard Error 2.4
|
-17.2 mg/dL
Standard Error 2.5
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: FAS observed cases (OC) (Only patients with available data are analysed)
Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.
Outcome measures
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=160 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=149 Participants
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=150 Participants
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=155 Participants
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=143 Participants
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=155 Participants
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=148 Participants
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=140 Participants
Oral administration of Metformin 500 mg bid
|
|---|---|---|---|---|---|---|---|---|
|
Body Weight Change From Baseline at Week 24
|
-3.78 kg
Standard Error 0.29
|
-3.04 kg
Standard Error 0.30
|
-3.48 kg
Standard Error 0.30
|
-2.77 kg
Standard Error 0.30
|
-2.38 kg
Standard Error 0.30
|
-2.39 kg
Standard Error 0.29
|
-1.27 kg
Standard Error 0.30
|
-0.52 kg
Standard Error 0.30
|
Adverse Events
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Empagliflozin 25 mg qd
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Empagliflozin 10 mg qd
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Metformin 1000 mg Bid
Serious events: 3 serious events
Other events: 53 other events
Deaths: 0 deaths
Metformin 500 mg Bid
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=170 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=170 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=171 participants at risk
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=169 participants at risk
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=167 participants at risk
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=172 participants at risk
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=170 participants at risk
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=171 participants at risk
Oral administration of Metformin 500 mg bid
|
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL
n=53 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.9%
1/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
General disorders
Chest pain
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.9%
1/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Dengue fever
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Herpes simplex encephalitis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Nervous system disorders
Cerebral infarction
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.9%
1/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.9%
1/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
Other adverse events
| Measure |
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid
n=170 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
|
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid
n=170 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
|
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid
n=171 participants at risk
Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
|
Empagliflozin 5 mg Bid + Metformin 500 mg Bid
n=169 participants at risk
Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
|
Empagliflozin 25 mg qd
n=167 participants at risk
Oral administration of Empagliflozin 25 mg once daily (qd)
|
Empagliflozin 10 mg qd
n=172 participants at risk
Oral administration of Empagliflozin 10 mg qd
|
Metformin 1000 mg Bid
n=170 participants at risk
Oral administration of Metformin 1000 mg bid
|
Metformin 500 mg Bid
n=171 participants at risk
Oral administration of Metformin 500 mg bid
|
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL
n=53 participants at risk
Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
12/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.5%
6/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.9%
5/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.3%
9/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.6%
6/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
14.1%
24/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.5%
6/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
7.5%
4/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.9%
5/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.7%
8/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.4%
4/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.2%
7/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.9%
5/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.9%
5/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.8%
10/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.7%
3/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Infections and infestations
Urinary tract infection
|
10.6%
18/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
10.0%
17/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
7.0%
12/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.3%
9/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
7.8%
13/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
7.0%
12/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
8.2%
14/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
7.0%
12/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.7%
8/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.5%
6/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.7%
8/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
8.9%
15/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
6.6%
11/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
8.7%
15/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.7%
8/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.1%
7/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.8%
2/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Nervous system disorders
Dizziness
|
3.5%
6/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.3%
9/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.3%
4/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.0%
5/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.8%
3/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.3%
4/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
4.1%
7/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.7%
3/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.59%
1/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.7%
3/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Gastrointestinal disorders
Nausea
|
3.5%
6/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.9%
5/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
3.0%
5/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.8%
3/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.7%
3/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
2.4%
4/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.58%
1/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/169 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.60%
1/167 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/172 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
1.2%
2/170 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
0.00%
0/171 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
5.7%
3/53 • Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER