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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:July 2012

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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

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


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
We found this trial at
33
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Winnipeg,
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