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24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182830
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Hypertension
Interventions Drug: Empagliflozin low dose
Drug: placebo
Drug: Empagliflozin high dose
Enrollment 166
Recruitment Details In this Phase 3b, multi-centre trial, a total of 719 patients were screened by 92 centres across the United States. The first centre was initiated on 25 Jul 2014. Of the 719 screened patients, 297 patients entered the placebo run-in phase of the trial and 166 were subsequently randomised to double-blind treatment
Pre-assignment Details Empagliflozin was administered at a starting dose of 10 milligram (mg) once daily. At Week 4, patients were dose escalated to a dose of 25 mg once daily. These doses were selected based on the results from previous dose-finding studies
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning) Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Period Title: Overall Study
Started 83 83
Randomised Set (RS) [1] 79 [2] 82 [3]
Treated Set (TS) [4] 77 [5] 80 [5]
Completed 68 68
Not Completed 15 15
Reason Not Completed
Not Treated             1             1
Trial stopped, reason missing             3             3
Consent withdrawn             8             8
Lost to Follow-up             3             3
[1]
Randomised Patients screened for trial, regardless of whether any trial drug was taken.
[2]
From started, 2 duplicate patients and 2 patients from one site were removed
[3]
From started, 1 patient from one site was removed
[4]
All patients in the RS who received at least one dose of trial medication.
[5]
From RS, 1 duplicate patient and 1 non treated patient was removed
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg Total
Hide Arm/Group Description Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning) Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks) Total of all reporting groups
Overall Number of Baseline Participants 72 78 150
Hide Baseline Analysis Population Description
Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment glycated haemoglobin (HbA1c)value. The FAS was the basis for the primary efficacy analysis.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 78 participants 150 participants
57.2  (9.3) 56.5  (9.3) 56.8  (9.3)
[1]
Measure Analysis Population Description: Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. The FAS was the basis for the primary efficacy analysis.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 78 participants 150 participants
Female
36
  50.0%
35
  44.9%
71
  47.3%
Male
36
  50.0%
43
  55.1%
79
  52.7%
[1]
Measure Analysis Population Description: FAS
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 78 participants 150 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
72
 100.0%
78
 100.0%
150
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: FAS
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 78 participants 150 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
72
 100.0%
78
 100.0%
150
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: FAS
Baseline hemoglobin A1c (HbA1c) [%]   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 72 participants 78 participants 150 participants
8.51  (1.12) 8.66  (0.92) 8.59  (1.02)
[1]
Measure Description: Mean and standard deviation for Baseline HbA1c [%] is presented
[2]
Measure Analysis Population Description: FAS
Baseline estimated glomerular filtration rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m²
Number Analyzed 72 participants 78 participants 150 participants
91.49  (20.79) 91.15  (18.95) 91.31  (19.79)
[1]
Measure Analysis Population Description: FAS
1.Primary Outcome
Title Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks
Hide Description

Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Full analysis set (FAS) observed cases (OC); FAS: All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value.

Observed cases will set all values measured after antidiabetic rescue medication to missing

Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: percentage of glycated haemoglobin
0.07  (0.14) -0.71  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM model : “HbA1c baseline,” “treatment,” “renal function,” “pre-treatment with metformin,” “visit,” “visit by treatment interaction,” and “HbA1c baseline by treatment interaction.” “Treatment,” “renal function,” “pre-treatment with metformin,” “visit,” and “visit by treatment interaction” were fixed classification effects, and “HbA1c baseline” was a linear covariate. The interaction “visit by HbA1c baseline interaction” was based on the linear covariate “HbA1c baseline.”
Type of Statistical Test Superiority
Comments A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.18 to -0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments Empagliflozin minus Placebo
2.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12
Hide Description

Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF-H; LOCF-H= Last observation carried forward without values following antidiabetic rescue medication and/or a change in antihypertensive therapy
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: millimeter of mercury (mmHg)
-0.90  (1.47) -6.10  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments

change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.

The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint.

Type of Statistical Test Superiority
Comments A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint
Statistical Test of Hypothesis P-Value 0.0117
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.21
Confidence Interval (2-Sided) 95%
-9.24 to -1.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.04
Estimation Comments Empagliflozin minus Placebo
3.Secondary Outcome
Title Changes From Baseline in Trough Mean Ambulatory SBP at Week 12
Hide Description

Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF-H
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: millimeter of mercury (mmHg)
-1.00  (1.89) -6.99  (1.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments

ANCOVA mode:

The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint.

Type of Statistical Test Superiority
Comments A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint
Statistical Test of Hypothesis P-Value 0.0237
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.99
Confidence Interval (2-Sided) 95%
-11.16 to -0.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.62
Estimation Comments Empagliflozin minus Placebo
4.Secondary Outcome
Title Change From Baseline in Body Weight at Week 24
Hide Description

Changes from baseline in body weight at Week 24 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: kilogram (kg)
-0.98  (0.42) -2.21  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.
Type of Statistical Test Superiority
Comments A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint
Statistical Test of Hypothesis P-Value 0.0382
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.23
Confidence Interval (2-Sided) 95%
-2.39 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.59
Estimation Comments Empagliflozin minus Placebo
5.Secondary Outcome
Title Change From Baseline in Trough Seated SBP at Week 12
Hide Description

Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-3.94  (1.82) -7.97  (1.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.
Type of Statistical Test Superiority
Comments A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint
Statistical Test of Hypothesis P-Value 0.1215
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.04
Confidence Interval (2-Sided) 95%
-9.16 to 1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.59
Estimation Comments Empagliflozin minus Placebo
6.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24
Hide Description

Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-1.94  (1.94) -10.33  (1.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -8.39
Confidence Interval (2-Sided) 95%
-13.74 to -3.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.69
Estimation Comments Empagliflozin minus Placebo
7.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12
Hide Description

Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-0.37  (0.90) -3.80  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.43
Confidence Interval (2-Sided) 95%
-5.90 to -0.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments Empagliflozin minus Placebo
8.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24
Hide Description

Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-1.48  (1.24) -6.38  (1.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.91
Confidence Interval (2-Sided) 95%
-8.35 to -1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments Empagliflozin minus Placebo
9.Secondary Outcome
Title Change From Baseline in Trough Seated SBP (mmHg) at Week 24
Hide Description

Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-2.83  (1.82) -10.26  (1.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.43
Confidence Interval (2-Sided) 95%
-12.37 to -2.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.50
Estimation Comments Empagliflozin minus Placebo
10.Secondary Outcome
Title Change From Baseline in Trough Seated DBP (mmHg) at Week 12
Hide Description

Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-2.30  (1.09) -4.14  (1.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2402
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-4.93 to 1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.56
Estimation Comments Empagliflozin minus Placebo
11.Secondary Outcome
Title Change From Baseline in Trough Seated DBP (mmHg) at Week 24
Hide Description

Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description:
Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)
Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Number of Participants Analyzed 72 78
Mean (Standard Error)
Unit of Measure: mmHg
-1.30  (1.09) -5.55  (1.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Empagliflozin 10 Mg-25mg
Comments MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.25
Confidence Interval (2-Sided) 95%
-7.21 to -1.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.49
Estimation Comments Empagliflozin minus Placebo
Time Frame All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks
Adverse Event Reporting Description All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
 
Arm/Group Title Placebo Empagliflozin 10 Mg-25mg
Hide Arm/Group Description Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning) Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
All-Cause Mortality
Placebo Empagliflozin 10 Mg-25mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/82 (0.00%) 
Hide Serious Adverse Events
Placebo Empagliflozin 10 Mg-25mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/80 (5.00%)   3/82 (3.66%) 
Cardiac disorders     
Cardiac failure congestive  1  0/80 (0.00%)  1/82 (1.22%) 
General disorders     
Chest pain  1  1/80 (1.25%)  1/82 (1.22%) 
Hepatobiliary disorders     
Drug-induced liver injury  1  0/80 (0.00%)  1/82 (1.22%) 
Injury, poisoning and procedural complications     
Overdose  1  0/80 (0.00%)  1/82 (1.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  1/80 (1.25%)  0/82 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/80 (1.25%)  0/82 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/80 (1.25%)  0/82 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Empagliflozin 10 Mg-25mg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/77 (10.39%)   12/80 (15.00%) 
Infections and infestations     
Upper respiratory tract infection  1  4/77 (5.19%)  2/80 (2.50%) 
Investigations     
Lipase increased  1  3/77 (3.90%)  6/80 (7.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/77 (1.30%)  5/80 (6.25%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182830    
Other Study ID Numbers: 1245.29
First Submitted: July 3, 2014
First Posted: July 8, 2014
Results First Submitted: May 16, 2018
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018