Status:
COMPLETED
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 mellitu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
1549 Patients enrolled
Trial Details
Trial ID
NCT01167881
Start Date
August 1 2010
End Date
August 1 2015
Last Update
September 2 2016
Active Locations (182)
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1
1245.28.10005 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
2
1245.28.10012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
3
1245.28.10016 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
4
1245.28.10003 Boehringer Ingelheim Investigational Site
Sacramento, California, United States