Status:
COMPLETED
Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of trea...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- patients completing one of double blind phase II trials 1245.9 or 1245.10
- informed consent
- Exclusion criteria:
- patients meeting withdrawal criteria of preceding trial
- significant hepatic impairment
- significant renal impairment with creatinine clearance \< 50 ml/min
- contraindication to Metformin for all patients treated with Metformin
- premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
- drug or alcohol abuse
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00881530
Start Date
March 1 2009
Last Update
June 16 2014
Active Locations (137)
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1
1245.24.101001 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
2
1245.24.101028 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
3
1245.24.101027 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
4
1245.24.101004 Boehringer Ingelheim Investigational Site
Clearwarter, Florida, United States