Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 treatment in patients with type 2 diabetes mellitus.

Key facts

Study ID

NCT00881530

Run by

Boehringer Ingelheim

People needed

660

Starts

2009-03-01

Last updated by the study team

2014-06-16

Who can join

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

You may qualify if…

• patients completing one of double blind phase II trials 1245.9 or 1245.10
• informed consent

You may not qualify if…

• 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

Where it is running

• 1245.24.101028 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 1245.24.101027 Boehringer Ingelheim Investigational Site — Walnut Creek, California, United States
• 1245.24.101004 Boehringer Ingelheim Investigational Site — Clearwarter, Florida, United States
• 1245.24.101005 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.24.101024 Boehringer Ingelheim Investigational Site — Saint Cloud, Florida, United States
• 1245.24.101014 Boehringer Ingelheim Investigational Site — Roswell, Georgia, United States
• 1245.24.101016 Boehringer Ingelheim Investigational Site — Staten Island, New York, United States
• 1245.24.101006 Boehringer Ingelheim Investigational Site — Wadsworth, Ohio, United States
• 1245.24.101023 Boehringer Ingelheim Investigational Site — Norristown, Pennsylvania, United States
• 1245.24.101015 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1245.24.101025 Boehringer Ingelheim Investigational Site — Federal Way, Washington, United States
• 1245.24.431002 Boehringer Ingelheim Investigational Site — Graz, Austria
• 1245.24.431001 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1245.24.431003 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1245.24.385104 Boehringer Ingelheim Investigational Site — Karlovac, Croatia
• 1245.24.385103 Boehringer Ingelheim Investigational Site — Krapinske Toplice, Croatia
• 1245.24.385106 Boehringer Ingelheim Investigational Site — Osijek, Croatia
• 1245.24.385101 Boehringer Ingelheim Investigational Site — Zagreb, Croatia
• 1245.24.420103 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1245.24.420105 Boehringer Ingelheim Investigational Site — Brno, Czechia
• 1245.24.420101 Boehringer Ingelheim Investigational Site — Břeclav, Czechia
• 1245.24.420102 Boehringer Ingelheim Investigational Site — Hodonín, Czechia
• 1245.24.372101 Boehringer Ingelheim Investigational Site — Tallinn, Estonia
• 1245.24.372102 Boehringer Ingelheim Investigational Site — Tallinn, Estonia
• 1245.24.101001 Boehringer Ingelheim Investigational Site — Mission Viejo, California, United States

Full record on ClinicalTrials.gov

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