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 |
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
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
sites
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