12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Completed · Phase 3 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2, Hypertension
In brief
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
Key facts
- Study ID
- NCT01370005
- Run by
- Boehringer Ingelheim
- People needed
- 825
- Starts
- 2011-06-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2016-02-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 1245.48.10002 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
- 1245.48.10014 Boehringer Ingelheim Investigational Site — Lincoln, California, United States
- 1245.48.10030 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
- 1245.48.10033 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
- 1245.48.10027 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
- 1245.48.10041 Boehringer Ingelheim Investigational Site — Tustin, California, United States
- 1245.48.10039 Boehringer Ingelheim Investigational Site — West Hills, California, United States
- 1245.48.10008 Boehringer Ingelheim Investigational Site — Davie, Florida, United States
- 1245.48.10025 Boehringer Ingelheim Investigational Site — Edgewater, Florida, United States
- 1245.48.10001 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
- 1245.48.10016 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
- 1245.48.10035 Boehringer Ingelheim Investigational Site — Palm Harbor, Florida, United States
- 1245.48.10018 Boehringer Ingelheim Investigational Site — Pensacola, Florida, United States
- 1245.48.10032 Boehringer Ingelheim Investigational Site — Pinellas Park, Florida, United States
- 1245.48.10012 Boehringer Ingelheim Investigational Site — Marietta, Georgia, United States
- 1245.48.10011 Boehringer Ingelheim Investigational Site — Addison, Illinois, United States
- 1245.48.10019 Boehringer Ingelheim Investigational Site — Arlington Heights, Illinois, United States
- 1245.48.10022 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
- 1245.48.10017 Boehringer Ingelheim Investigational Site — Wichita, Kansas, United States
- 1245.48.10010 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
- 1245.48.10036 Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
- 1245.48.10005 Boehringer Ingelheim Investigational Site — Akron, Ohio, United States
- 1245.48.10004 Boehringer Ingelheim Investigational Site — Kettering, Ohio, United States
- 1245.48.10013 Boehringer Ingelheim Investigational Site — Erie, Pennsylvania, United States
- 1245.48.10024 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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