Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: BI 10773 Drug: Metformin Drug: BI 10773 Drug: Sitagliptin |
Phase | Phase 2 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT00881530 |
First Received | April 14, 2009 |
Last Updated | September 27, 2012 |
Last verified | September 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 14, 2009 |
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Last Updated Date | September 27, 2012 |
Start Date | March 2009 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension |
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Official Title | A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients |
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 treatment in patients with type 2 diabetes mellitus. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: BI 10773 BI 10773 high dose once daily Drug: Metformin open label comparator Drug: BI 10773 BI 10773 low dose once daily Drug: Sitagliptin open label comparator |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 660 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | May 2011 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Norway, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Ukraine |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00881530 |
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Other Study ID Numbers | 1245.24 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Not Provided |
Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
Verification Date | September 2012 |
Locations[ + expand ][ + ]
1245.24.101001 Boehringer Ingelheim Investigational Site | Mission Viejo, California, United States |
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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 | St. 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 |
1245.24.431003 Boehringer Ingelheim Investigational Site | Wien, Austria |
1245.24.431001 Boehringer Ingelheim Investigational Site | Wien, 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 |
1245.24.420101 Boehringer Ingelheim Investigational Site | Breclav, Czech Republic |
1245.24.420103 Boehringer Ingelheim Investigational Site | Brno, Czech Republic |
1245.24.420105 Boehringer Ingelheim Investigational Site | Brno, Czech Republic |
1245.24.420102 Boehringer Ingelheim Investigational Site | Hodonin, Czech Republic |
1245.24.372103 Boehringer Ingelheim Investigational Site | Tallinn, Estonia |
1245.24.372104 Boehringer Ingelheim Investigational Site | Tallinn, Estonia |
1245.24.372102 Boehringer Ingelheim Investigational Site | Tallinn, Estonia |
1245.24.372101 Boehringer Ingelheim Investigational Site | Tallinn, Estonia |
1245.24.372105 Boehringer Ingelheim Investigational Site | Tartu, Estonia |
1245.24.581006 Boehringer Ingelheim Investigational Site | Kerava, Finland |
1245.24.581003 Boehringer Ingelheim Investigational Site | Oulu, Finland |
1245.24.581004 Boehringer Ingelheim Investigational Site | Tampere, Finland |
1245.24.581001 Boehringer Ingelheim Investigational Site | Turku, Finland |
1245.24.3302B Boehringer Ingelheim Investigational Site | Bondy Cedex, France |
1245.24.3302A Boehringer Ingelheim Investigational Site | Bondy Cedex, France |
1245.24.3310C Boehringer Ingelheim Investigational Site | Caen Cedex 5, France |
1245.24.3310A Boehringer Ingelheim Investigational Site | Caen Cedex 5, France |
1245.24.3301A Boehringer Ingelheim Investigational Site | Corbeil Essonnes, France |
1245.24.3303A Boehringer Ingelheim Investigational Site | La Rochelle Cedex 1, France |
1245.24.3303B Boehringer Ingelheim Investigational Site | La Rochelle Cedex 1, France |
1245.24.3309A Boehringer Ingelheim Investigational Site | Nanterre Cedex, France |
1245.24.3306A Boehringer Ingelheim Investigational Site | Narbonne Cedex, France |
1245.24.3304A Boehringer Ingelheim Investigational Site | Reims Cedex, France |
1245.24.3311B Boehringer Ingelheim Investigational Site | Saint Mandé, France |
1245.24.3305B Boehringer Ingelheim Investigational Site | Valenciennes, France |
1245.24.3305A Boehringer Ingelheim Investigational Site | Valenciennes, France |
1245.24.491011 Boehringer Ingelheim Investigational Site | Aschaffenburg, Germany |
1245.24.491007 Boehringer Ingelheim Investigational Site | Frankfurt am Main, Germany |
1245.24.491005 Boehringer Ingelheim Investigational Site | Hamburg, Germany |
1245.24.491004 Boehringer Ingelheim Investigational Site | Hamburg, Germany |
1245.24.491002 Boehringer Ingelheim Investigational Site | Melsungen, Germany |
1245.24.491012 Boehringer Ingelheim Investigational Site | Nürnberg, Germany |
1245.24.491008 Boehringer Ingelheim Investigational Site | Rehlingen-Siersburg, Germany |
1245.24.491003 Boehringer Ingelheim Investigational Site | St. Ingbert/Oberwürzbach, Germany |
1245.24.491010 Boehringer Ingelheim Investigational Site | Sulzbach-Rosenberg, Germany |
1245.24.361003 Boehringer Ingelheim Investigational Site | Budapest, Hungary |
1245.24.361004 Boehringer Ingelheim Investigational Site | Budapest, Hungary |
1245.24.361001 Boehringer Ingelheim Investigational Site | Budapest, Hungary |
1245.24.361005 Boehringer Ingelheim Investigational Site | Gyor, Hungary |
1245.24.361002 Boehringer Ingelheim Investigational Site | Szombathely, Hungary |
1245.24.391006 Boehringer Ingelheim Investigational Site | Genova, Italy |
1245.24.391003 Boehringer Ingelheim Investigational Site | Pisa, Italy |
1245.24.391005 Boehringer Ingelheim Investigational Site | Treviso, Italy |
1245.24.821008 Boehringer Ingelheim Investigational Site | Goyang, Korea, Republic of |
1245.24.821006 Boehringer Ingelheim Investigational Site | Goyang, Korea, Republic of |
1245.24.821007 Boehringer Ingelheim Investigational Site | Incheon, Korea, Republic of |
1245.24.821002 Boehringer Ingelheim Investigational Site | Pucheon, Korea, Republic of |
1245.24.821004 Boehringer Ingelheim Investigational Site | Seoul, Korea, Republic of |
1245.24.821001 Boehringer Ingelheim Investigational Site | Seoul, Korea, Republic of |
1245.24.821009 Boehringer Ingelheim Investigational Site | Suwon, Korea, Republic of |
1245.24.821003 Boehringer Ingelheim Investigational Site | Uijeongbu, Korea, Republic of |
1245.24.371101 Boehringer Ingelheim Investigational Site | Daugavpils, Latvia |
1245.24.371105 Boehringer Ingelheim Investigational Site | Kuldiga, Latvia |
1245.24.371106 Boehringer Ingelheim Investigational Site | Ogre, Latvia |
1245.24.371107 Boehringer Ingelheim Investigational Site | Riga, Latvia |
1245.24.371103 Boehringer Ingelheim Investigational Site | Riga, Latvia |
1245.24.371102 Boehringer Ingelheim Investigational Site | Talsi, Latvia |
1245.24.371104 Boehringer Ingelheim Investigational Site | Valmiera, Latvia |
1245.24.370102 Boehringer Ingelheim Investigational Site | Klaipeda, Lithuania |
1245.24.370101 Boehringer Ingelheim Investigational Site | Vilnius, Lithuania |
1245.24.471003 Boehringer Ingelheim Investigational Site | Hamar, Norway |
1245.24.471005 Boehringer Ingelheim Investigational Site | Oslo, Norway |
1245.24.471001 Boehringer Ingelheim Investigational Site | Stavanger, Norway |
1245.24.471004 Boehringer Ingelheim Investigational Site | Ålesund, Norway |
1245.24.401005 Boehringer Ingelheim Investigational Site | Alba Iulia, Romania |
1245.24.401006 Boehringer Ingelheim Investigational Site | Baia Mare Maramures, Romania |
1245.24.401002 Boehringer Ingelheim Investigational Site | Brasov, Romania |
1245.24.401008 Boehringer Ingelheim Investigational Site | Bucharest, Romania |
1245.24.401001 Boehringer Ingelheim Investigational Site | Bucharest, Romania |
1245.24.401003 Boehringer Ingelheim Investigational Site | Galati, Romania |
1245.24.401007 Boehringer Ingelheim Investigational Site | Satu Mare, Romania |
1245.24.401004 Boehringer Ingelheim Investigational Site | Targu-Mures, Romania |
1245.24.701001 Boehringer Ingelheim Investigational Site | Ekaterinburg, Russian Federation |
1245.24.701002 Boehringer Ingelheim Investigational Site | Kazan, Russian Federation |
1245.24.701008 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1245.24.701010 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1245.24.701009 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1245.24.701004 Boehringer Ingelheim Investigational Site | Petrozavodsk, Russian Federation |
1245.24.701014 Boehringer Ingelheim Investigational Site | Saratov, Russian Federation |
1245.24.701005 Boehringer Ingelheim Investigational Site | Smolensk, Russian Federation |
1245.24.701013 Boehringer Ingelheim Investigational Site | St. Petersburg, Russian Federation |
1245.24.701012 Boehringer Ingelheim Investigational Site | St. Petersburg, Russian Federation |
1245.24.701006 Boehringer Ingelheim Investigational Site | Yaroslavl, Russian Federation |
1245.24.701007 Boehringer Ingelheim Investigational Site | Yaroslavl, Russian Federation |
1245.24.421107 Boehringer Ingelheim Investigational Site | Bratislava, Slovakia |
1245.24.421102 Boehringer Ingelheim Investigational Site | Bratislava, Slovakia |
1245.24.421103 Boehringer Ingelheim Investigational Site | Lucenec, Slovakia |
1245.24.421106 Boehringer Ingelheim Investigational Site | Nitra, Slovakia |
1245.24.421105 Boehringer Ingelheim Investigational Site | Nitra, Slovakia |
1245.24.421104 Boehringer Ingelheim Investigational Site | Nove Mesto Nad Vahom, Slovakia |
1245.24.421108 Boehringer Ingelheim Investigational Site | Presov, Slovakia |
1245.24.421101 Boehringer Ingelheim Investigational Site | Prievidza, Slovakia |
1245.24.341002 Boehringer Ingelheim Investigational Site | Barcelona, Spain |
1245.24.341001 Boehringer Ingelheim Investigational Site | Girona, Spain |
1245.24.341010 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona), Spain |
1245.24.341004 Boehringer Ingelheim Investigational Site | Málaga, Spain |
1245.24.341005 Boehringer Ingelheim Investigational Site | Palma Mallorca, Spain |
1245.24.341006 Boehringer Ingelheim Investigational Site | Palma Mallorca, Spain |
1245.24.341008 Boehringer Ingelheim Investigational Site | Santander, Spain |
1245.24.461004 Boehringer Ingelheim Investigational Site | Härnösand, Sweden |
1245.24.461005 Boehringer Ingelheim Investigational Site | Lund, Sweden |
1245.24.461001 Boehringer Ingelheim Investigational Site | Stockholm, Sweden |
1245.24.886105 Boehringer Ingelheim Investigational Site | Changhua, Taiwan |
1245.24.886107 Boehringer Ingelheim Investigational Site | Kaohsiung, Taiwan |
1245.24.886104 Boehringer Ingelheim Investigational Site | Taichun, Taiwan |
1245.24.886106 Boehringer Ingelheim Investigational Site | Tainan, Taiwan |
1245.24.886103 Boehringer Ingelheim Investigational Site | Taipei, Taiwan |
1245.24.886101 Boehringer Ingelheim Investigational Site | Taipei, Taiwan |
1245.24.886102 Boehringer Ingelheim Investigational Site | Taoyuan, Taiwan |
1245.24.381007 Boehringer Ingelheim Investigational Site | Dnepropetrovsk, Ukraine |
1245.24.381010 Boehringer Ingelheim Investigational Site | Kharkiv, Ukraine |
1245.24.381009 Boehringer Ingelheim Investigational Site | Kharkov, Ukraine |
1245.24.381003 Boehringer Ingelheim Investigational Site | Kharkov, Ukraine |
1245.24.381008 Boehringer Ingelheim Investigational Site | Kiev, Ukraine |
1245.24.381002 Boehringer Ingelheim Investigational Site | Odessa, Ukraine |
1245.24.381006 Boehringer Ingelheim Investigational Site | Vinnitsa, Ukraine |
1245.24.381001 Boehringer Ingelheim Investigational Site | Vinnytsya, Ukraine |
1245.24.381005 Boehringer Ingelheim Investigational Site | Vinnytsya, Ukraine |