12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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

Official Title
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A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Drug: Placebo
* Drug: BI 10773
* Drug: Placebo
* Drug: BI 10773
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients >=18 years with type 2 diabetes HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol) Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization Known or suspected secondary hypertension Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 10773 low dose<br>BI 10773 low dose once daily | Drug: Placebo<br>* Placebo matching BI 10773 low dose<br>Drug: BI 10773<br>* BI 10773 low dose once daily<br>|
| Experimental: BI 10773 high dose<br>BI 10773 high dose once daily | Drug: BI 10773<br>* BI 10773 high dose once daily<br>Drug: Placebo<br>* Placebo matching BI 10773 high dose<br>|
| Placebo Comparator: Placebo<br>Placebo tablets matching BI 10773 | Drug: Placebo<br>* Placebo matching BI 10773 low dose<br>Drug: Placebo<br>* Placebo matching BI 10773 high dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Change From Baseline | Change from baseline in HbA1c after 12 weeks of treatment. | Baseline and 12 weeks | 
| Mean 24-hour Systolic Blood Pressure Change From Baseline | Change from baseline of mean 24-hour systolic blood pressure (SBP). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour Diastolic Blood Pressure Change From Baseline | Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks. | Baseline and 12 weeks | 
| Proportion of Patients With HbA1c <7% | Proportion of patients with HbA1c <7% after 12 weeks. | Baseline and 12 weeks | 
| Fasting Plasma Glucose (FPG) Change From Baseline | Change from baseline in FPG after 12 weeks of treatment. | Baseline and 12 weeks | 
| Body Weight Change From Baseline | Change from baseline in body weight after 12 weeks of treatment. | Baseline and 12 weeks | 
| Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline | Change from baseline in daytime mean SBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline | Change from baseline in daytime mean DBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline | Change from baseline in nighttime mean SBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline | Change from baseline in nighttime mean DBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline | Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline | Change from baseline in trough mean seated DBP after 12 weeks of treatment. | Baseline and 12 weeks | 
| Proportion of Patients Reaching Blood Pressure <130/80 mmHg | Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment | Baseline and 12 weeks | 
| 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% | Baseline and 12 weeks | 
| Orthostatic Blood Pressure | Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment. | Baseline and 12 weeks |