Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773
Interventions
DRUGPlacebo
Placebo matching BI 10773 low dose
DRUGBI 10773
BI 10773 high dose once daily
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients \>=18 years with type 2 diabetes 2. HbA1c of \>= 7.0% (53 mmol/mol) and =\< 10% (86 mmol/mol) 3. Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg
Exclusion criteria
1. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast before randomization 2. Known or suspected secondary hypertension 3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour Systolic Blood Pressure Change From Baseline | Baseline and 12 weeks | Change from baseline of mean 24-hour systolic blood pressure (SBP). |
| HbA1c Change From Baseline | Baseline and 12 weeks | Change from baseline in HbA1c after 12 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With HbA1c <7% | Baseline and 12 weeks | Proportion of patients with HbA1c \<7% after 12 weeks. |
| Fasting Plasma Glucose (FPG) Change From Baseline | Baseline and 12 weeks | Change from baseline in FPG after 12 weeks of treatment. |
| Body Weight Change From Baseline | Baseline and 12 weeks | Change from baseline in body weight after 12 weeks of treatment. |
| Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in daytime mean SBP after 12 weeks of treatment. |
| Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in daytime mean DBP after 12 weeks of treatment. |
| Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in nighttime mean SBP after 12 weeks of treatment. |
| Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment. |
| Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in trough mean seated DBP after 12 weeks of treatment. |
| Proportion of Patients Reaching Blood Pressure <130/80 mmHg | Baseline and 12 weeks | Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment |
| Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Baseline and 12 weeks | 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% |
| Orthostatic Blood Pressure | Baseline and 12 weeks | Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment. |
| Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline | Baseline and 12 weeks | Change from baseline in nighttime mean DBP after 12 weeks of treatment. |
| Mean 24-hour Diastolic Blood Pressure Change From Baseline | Baseline and 12 weeks | Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Hypoglycaemic Adverse Events | From drug administration until last drug administration plus seven days, up to 171 days | Number of participants with confirmed hypoglycaemic adverse events |
Countries
Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Lebanon, Netherlands, Norway, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks. | 271 |
| Empa 10mg Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks. | 276 |
| Empa 25mg Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks. | 276 |
| Total | 823 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 | 6 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Non compliant with protocol | 0 | 1 | 2 |
| Overall Study | Not treated | 1 | 0 | 0 |
| Overall Study | Other reason not defined above | 3 | 0 | 2 |
| Overall Study | Patient refusal to continue,not due toAE | 5 | 4 | 0 |
Baseline characteristics
| Characteristic | Placebo | Empa 10mg | Empa 25mg | Total |
|---|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 8.8 | 60.6 years STANDARD_DEVIATION 8.5 | 59.9 years STANDARD_DEVIATION 9.7 | 60.2 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 103 Participants | 105 Participants | 120 Participants | 328 Participants |
| Sex: Female, Male Male | 168 Participants | 171 Participants | 156 Participants | 495 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 272 | 42 / 276 | 55 / 276 |
| serious Total, serious adverse events | 7 / 272 | 3 / 276 | 4 / 276 |
Outcome results
Primary
HbA1c Change From Baseline
Change from baseline in HbA1c after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline | 0.03 percentage of HbA1c | Standard Deviation 0.6 |
| Empa 10mg | HbA1c Change From Baseline | -0.59 percentage of HbA1c | Standard Deviation 0.63 |
| Empa 25mg | HbA1c Change From Baseline | -0.63 percentage of HbA1c | Standard Deviation 0.62 |
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: <0.000195% CI: [-0.72, -0.52]ANCOVA
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: <0.000195% CI: [-0.75, -0.55]ANCOVA
Primary
Mean 24-hour Systolic Blood Pressure Change From Baseline
Change from baseline of mean 24-hour systolic blood pressure (SBP).
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean 24-hour Systolic Blood Pressure Change From Baseline | 0.42 mmHg | Standard Deviation 8.25 |
| Empa 10mg | Mean 24-hour Systolic Blood Pressure Change From Baseline | -2.99 mmHg | Standard Deviation 8.86 |
| Empa 25mg | Mean 24-hour Systolic Blood Pressure Change From Baseline | -3.59 mmHg | Standard Deviation 9.3 |
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: <0.000195% CI: [-4.78, -2.09]ANCOVA
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: <0.000195% CI: [-5.5, -2.83]ANCOVA
Secondary
Body Weight Change From Baseline
Change from baseline in body weight after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Body Weight Change From Baseline | -0.19 kg | Standard Deviation 1.55 |
| Empa 10mg | Body Weight Change From Baseline | -1.67 kg | Standard Deviation 2.38 |
| Empa 25mg | Body Weight Change From Baseline | -2.16 kg | Standard Deviation 2.38 |
p-value: <0.000195% CI: [-1.85, -1.13]ANCOVA
p-value: <0.000195% CI: [-2.33, -1.62]ANCOVA
Secondary
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight
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%
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number fulfilled | 6 participants |
| Placebo | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number not fulfilled | 265 participants |
| Empa 10mg | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number fulfilled | 41 participants |
| Empa 10mg | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number not fulfilled | 235 participants |
| Empa 25mg | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number fulfilled | 58 participants |
| Empa 25mg | Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight | Number not fulfilled | 218 participants |
Secondary
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Change from baseline in daytime mean DBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline | 0.26 mmHg | Standard Deviation 5.36 |
| Empa 10mg | Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline | -1.28 mmHg | Standard Deviation 5.41 |
| Empa 25mg | Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline | -1.58 mmHg | Standard Deviation 5.35 |
p-value: 0.000495% CI: [-2.42, -0.69]ANCOVA
p-value: <0.000195% CI: [-2.84, -1.12]ANCOVA
Secondary
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline
Change from baseline in daytime mean SBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline | 0.38 mmHg | Standard Deviation 8.74 |
| Empa 10mg | Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline | -3.40 mmHg | Standard Deviation 9.55 |
| Empa 25mg | Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline | -4.12 mmHg | Standard Deviation 9.55 |
p-value: <0.000195% CI: [-5.37, -2.52]ANCOVA
p-value: <0.000195% CI: [-6.2, -3.36]ANCOVA
Secondary
Fasting Plasma Glucose (FPG) Change From Baseline
Change from baseline in FPG after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Fasting Plasma Glucose (FPG) Change From Baseline | 7.19 mg/dL | Standard Deviation 38.29 |
| Empa 10mg | Fasting Plasma Glucose (FPG) Change From Baseline | -15.23 mg/dL | Standard Deviation 33.32 |
| Empa 25mg | Fasting Plasma Glucose (FPG) Change From Baseline | -24.45 mg/dL | Standard Deviation 35.38 |
p-value: <0.000195% CI: [-28.91, -18.6]ANCOVA
p-value: <0.000195% CI: [-35.32, -25.08]ANCOVA
Secondary
Mean 24-hour Diastolic Blood Pressure Change From Baseline
Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean 24-hour Diastolic Blood Pressure Change From Baseline | 0.30 mmHg | Standard Deviation 5.06 |
| Empa 10mg | Mean 24-hour Diastolic Blood Pressure Change From Baseline | -1.10 mmHg | Standard Deviation 4.96 |
| Empa 25mg | Mean 24-hour Diastolic Blood Pressure Change From Baseline | -1.32 mmHg | Standard Deviation 4.96 |
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: 0.000895% CI: [-2.15, -0.56]ANCOVA
Comparison: Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.p-value: <0.000195% CI: [-2.51, -0.93]ANCOVA
Secondary
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline
Change from baseline in nighttime mean DBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline | 0.36 mmHg | Standard Deviation 6.8 |
| Empa 10mg | Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline | -0.80 mmHg | Standard Deviation 6.21 |
| Empa 25mg | Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline | -0.75 mmHg | Standard Deviation 6.32 |
p-value: 0.056695% CI: [-1.93, 0.03]ANCOVA
p-value: 0.020895% CI: [-2.12, -0.18]ANCOVA
Secondary
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline
Change from baseline in nighttime mean SBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline | 0.51 mmHg | Standard Deviation 10.22 |
| Empa 10mg | Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline | -2.22 mmHg | Standard Deviation 10.21 |
| Empa 25mg | Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline | -2.47 mmHg | Standard Deviation 11.09 |
p-value: 0.002195% CI: [-4.09, -0.91]ANCOVA
p-value: 0.000395% CI: [-4.48, -1.32]ANCOVA
Secondary
Orthostatic Blood Pressure
Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Orthostatic Blood Pressure | Baseline: Positive | 42 participants |
| Placebo | Orthostatic Blood Pressure | Baseline: Negative | 212 participants |
| Placebo | Orthostatic Blood Pressure | Week 12: Positive | 51 participants |
| Placebo | Orthostatic Blood Pressure | Week 12: Negative | 203 participants |
| Empa 10mg | Orthostatic Blood Pressure | Week 12: Negative | 192 participants |
| Empa 10mg | Orthostatic Blood Pressure | Baseline: Positive | 40 participants |
| Empa 10mg | Orthostatic Blood Pressure | Week 12: Positive | 67 participants |
| Empa 10mg | Orthostatic Blood Pressure | Baseline: Negative | 219 participants |
| Empa 25mg | Orthostatic Blood Pressure | Week 12: Negative | 183 participants |
| Empa 25mg | Orthostatic Blood Pressure | Baseline: Negative | 208 participants |
| Empa 25mg | Orthostatic Blood Pressure | Week 12: Positive | 76 participants |
| Empa 25mg | Orthostatic Blood Pressure | Baseline: Positive | 51 participants |
Secondary
Proportion of Patients Reaching Blood Pressure <130/80 mmHg
Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Reaching Blood Pressure <130/80 mmHg | 19 participants |
| Empa 10mg | Proportion of Patients Reaching Blood Pressure <130/80 mmHg | 45 participants |
| Empa 25mg | Proportion of Patients Reaching Blood Pressure <130/80 mmHg | 40 participants |
p-value: 0.002195% CI: [1.39, 4.45]Regression, Logistic
p-value: 0.008895% CI: [1.22, 3.96]Regression, Logistic
Secondary
Proportion of Patients With HbA1c <7%
Proportion of patients with HbA1c \<7% after 12 weeks.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients With HbA1c <7% | 18 participants |
| Empa 10mg | Proportion of Patients With HbA1c <7% | 79 participants |
| Empa 25mg | Proportion of Patients With HbA1c <7% | 79 participants |
p-value: <0.000195% CI: [3.51, 11.18]Regression, Logistic
p-value: <0.000195% CI: [3.7, 11.75]Regression, Logistic
Secondary
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline
Change from baseline in trough mean seated DBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline | -1.02 mmHg | Standard Deviation 6.58 |
| Empa 10mg | Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline | -3.18 mmHg | Standard Deviation 7.1 |
| Empa 25mg | Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline | -3.01 mmHg | Standard Deviation 7.05 |
p-value: 0.000595% CI: [-3.01, -0.84]ANCOVA
p-value: 0.000695% CI: [-2.97, -0.82]ANCOVA
Secondary
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline
Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline | -0.57 mmHg | Standard Deviation 11.92 |
| Empa 10mg | Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline | -4.73 mmHg | Standard Deviation 12.54 |
| Empa 25mg | Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline | -5.45 mmHg | Standard Deviation 12.43 |
p-value: <0.000195% CI: [-5.86, -1.98]ANCOVA
p-value: <0.000195% CI: [-6.73, -2.87]ANCOVA
Other Pre-specified
Confirmed Hypoglycaemic Adverse Events
Number of participants with confirmed hypoglycaemic adverse events
Time frame: From drug administration until last drug administration plus seven days, up to 171 days
Population: Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Confirmed Hypoglycaemic Adverse Events | 13 participants |
| Empa 10mg | Confirmed Hypoglycaemic Adverse Events | 18 participants |
| Empa 25mg | Confirmed Hypoglycaemic Adverse Events | 17 participants |