Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Key facts

Study ID

NCT01167881

Run by

Boehringer Ingelheim

People needed

1549

Starts

2010-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis typ 2 diabetes mellitus
• Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
• HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
• 18 years or more
• BMI equal or less than 45Kg/m2

You may not qualify if…

• Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
• Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
• Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
• Indication of liver disease
• Moderate to severe renal impairment
• Bariatric surgery within past 2 years
• Medical history of cancer or treatment for cancer within last 5 years
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
• Contraindications hypersensitivity to concomitant drugs
• Treatment with anti-obesity drugs

Where it is running

• 1245.28.10012 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1245.28.10016 Boehringer Ingelheim Investigational Site — Hot Springs, Arkansas, United States
• 1245.28.10003 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 1245.28.10021 Boehringer Ingelheim Investigational Site — West Hills, California, United States
• 1245.28.10009 Boehringer Ingelheim Investigational Site — Bradednton, Florida, United States
• 1245.28.10015 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1245.28.10033 Boehringer Ingelheim Investigational Site — Blue Ridge, Georgia, United States
• 1245.28.10026 Boehringer Ingelheim Investigational Site — Boise, Idaho, United States
• 1245.28.10007 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1245.28.10027 Boehringer Ingelheim Investigational Site — Henderson, Nevada, United States
• 1245.28.10014 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
• 1245.28.10006 Boehringer Ingelheim Investigational Site — Shelby, North Carolina, United States
• 1245.28.10011 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1245.28.10019 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1245.28.10004 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1245.28.10008 Boehringer Ingelheim Investigational Site — Perrysburg, Ohio, United States
• 1245.28.10020 Boehringer Ingelheim Investigational Site — Medford, Oregon, United States
• 1245.28.10017 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
• 1245.28.10031 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1245.28.10032 Boehringer Ingelheim Investigational Site — Longview, Texas, United States
• 1245.28.10022 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1245.28.10030 Boehringer Ingelheim Investigational Site — Draper, Utah, United States
• 1245.28.10023 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 1245.28.10013 Boehringer Ingelheim Investigational Site — Kenosha, Wisconsin, United States
• 1245.28.10005 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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