Trial Outcomes & Findings for 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus (NCT NCT01370005)
NCT ID: NCT01370005
Last Updated: 2016-02-22
Results Overview
Change from baseline in HbA1c after 12 weeks of treatment.
COMPLETED
PHASE3
825 participants
Baseline and 12 weeks
2016-02-22
Participant Flow
Participant milestones
| Measure |
Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
272
|
276
|
277
|
|
Overall Study
COMPLETED
|
256
|
265
|
266
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
11
|
Reasons for withdrawal
| Measure |
Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Non compliant with protocol
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Patient refusal to continue,not due toAE
|
5
|
4
|
0
|
|
Overall Study
Other reason not defined above
|
3
|
0
|
2
|
Baseline Characteristics
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
Total
n=823 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
60.6 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
59.9 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
60.2 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
328 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
495 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Change from baseline in HbA1c after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
HbA1c Change From Baseline
|
0.03 percentage of HbA1c
Standard Deviation 0.60
|
-0.59 percentage of HbA1c
Standard Deviation 0.63
|
-0.63 percentage of HbA1c
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline of mean 24-hour systolic blood pressure (SBP).
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Mean 24-hour Systolic Blood Pressure Change From Baseline
|
0.42 mmHg
Standard Deviation 8.25
|
-2.99 mmHg
Standard Deviation 8.86
|
-3.59 mmHg
Standard Deviation 9.30
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Mean 24-hour Diastolic Blood Pressure Change From Baseline
|
0.30 mmHg
Standard Deviation 5.06
|
-1.10 mmHg
Standard Deviation 4.96
|
-1.32 mmHg
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Patients in the full analysis set (FAS) and with baseline HbA1c \>= 7%. Treatment assignment as randomised. Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule.
Proportion of patients with HbA1c \<7% after 12 weeks.
Outcome measures
| Measure |
Placebo
n=252 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=256 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=264 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Proportion of Patients With HbA1c <7%
|
18 participants
|
79 participants
|
79 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in FPG after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline
|
7.19 mg/dL
Standard Deviation 38.29
|
-15.23 mg/dL
Standard Deviation 33.32
|
-24.45 mg/dL
Standard Deviation 35.38
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in body weight after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Body Weight Change From Baseline
|
-0.19 kg
Standard Deviation 1.55
|
-1.67 kg
Standard Deviation 2.38
|
-2.16 kg
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in daytime mean SBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
|
0.38 mmHg
Standard Deviation 8.74
|
-3.40 mmHg
Standard Deviation 9.55
|
-4.12 mmHg
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in daytime mean DBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline
|
0.26 mmHg
Standard Deviation 5.36
|
-1.28 mmHg
Standard Deviation 5.41
|
-1.58 mmHg
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in nighttime mean SBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline
|
0.51 mmHg
Standard Deviation 10.22
|
-2.22 mmHg
Standard Deviation 10.21
|
-2.47 mmHg
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in nighttime mean DBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline
|
0.36 mmHg
Standard Deviation 6.80
|
-0.80 mmHg
Standard Deviation 6.21
|
-0.75 mmHg
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline
|
-0.57 mmHg
Standard Deviation 11.92
|
-4.73 mmHg
Standard Deviation 12.54
|
-5.45 mmHg
Standard Deviation 12.43
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised. Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.
Change from baseline in trough mean seated DBP after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline
|
-1.02 mmHg
Standard Deviation 6.58
|
-3.18 mmHg
Standard Deviation 7.10
|
-3.01 mmHg
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP\<80 mmHg and SBP \<130 mmHg. Treatment assignment as randomised. Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule.
Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=241 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=251 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=247 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Proportion of Patients Reaching Blood Pressure <130/80 mmHg
|
19 participants
|
45 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Patients in the full analysis set (FAS). Treatment assignment as randomised. Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule.
A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure \> 3 mmHg from baseline and reduction of weight from baseline \> 2%
Outcome measures
| Measure |
Placebo
n=271 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
Number fulfilled
|
6 participants
|
41 participants
|
58 participants
|
|
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
Number not fulfilled
|
265 participants
|
235 participants
|
218 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.
Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=254 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=259 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=259 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Orthostatic Blood Pressure
Baseline: Positive
|
42 participants
|
40 participants
|
51 participants
|
|
Orthostatic Blood Pressure
Baseline: Negative
|
212 participants
|
219 participants
|
208 participants
|
|
Orthostatic Blood Pressure
Week 12: Positive
|
51 participants
|
67 participants
|
76 participants
|
|
Orthostatic Blood Pressure
Week 12: Negative
|
203 participants
|
192 participants
|
183 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From drug administration until last drug administration plus seven days, up to 171 daysPopulation: Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.
Number of participants with confirmed hypoglycaemic adverse events
Outcome measures
| Measure |
Placebo
n=272 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Confirmed Hypoglycaemic Adverse Events
|
13 participants
|
18 participants
|
17 participants
|
Adverse Events
Placebo
Empa 10mg
Empa 25mg
Serious adverse events
| Measure |
Placebo
n=272 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Cardiac disorders
Angina pectoris
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Renal and urinary disorders
Urethral stenosis
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
General disorders
Chest pain
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
General disorders
Sudden death
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.36%
1/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.00%
0/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
Other adverse events
| Measure |
Placebo
n=272 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
|
Empa 10mg
n=276 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
|
Empa 25mg
n=276 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.6%
26/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
5.4%
15/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
7.2%
20/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.1%
14/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
6.9%
19/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
6.9%
19/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
7/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
4.0%
11/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
6.2%
17/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
|
General disorders
Thirst
|
0.37%
1/272 • From drug administration until last drug administration plus seven days, up to 171 days
|
0.72%
2/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
5.4%
15/276 • From drug administration until last drug administration plus seven days, up to 171 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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