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

NCT ID: NCT00881530

Last Updated: 2014-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin

100 mg

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

open label comparator

Metformin

2000 mg

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

open label comparator

BI 10773 X mg

lower dose

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 low dose once daily

BI 10773 Y mg

higher dose

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 high dose once daily

Interventions

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BI 10773

BI 10773 high dose once daily

Intervention Type DRUG

Metformin

open label comparator

Intervention Type DRUG

BI 10773

BI 10773 low dose once daily

Intervention Type DRUG

Sitagliptin

open label comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.24.101001 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Site Status

1245.24.101028 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Site Status

1245.24.101027 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Site Status

1245.24.101004 Boehringer Ingelheim Investigational Site

Clearwarter, Florida, United States

Site Status

1245.24.101005 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.24.101024 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Site Status

1245.24.101014 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

1245.24.101016 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

Site Status

1245.24.101006 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

Site Status

1245.24.101023 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Site Status

1245.24.101015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1245.24.101025 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Site Status

1245.24.431002 Boehringer Ingelheim Investigational Site

Graz, , Austria

Site Status

1245.24.431001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1245.24.431003 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1245.24.385104 Boehringer Ingelheim Investigational Site

Karlovac, , Croatia

Site Status

1245.24.385103 Boehringer Ingelheim Investigational Site

Krapinske Toplice, , Croatia

Site Status

1245.24.385106 Boehringer Ingelheim Investigational Site

Osijek, , Croatia

Site Status

1245.24.385101 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1245.24.420103 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1245.24.420105 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1245.24.420101 Boehringer Ingelheim Investigational Site

Břeclav, , Czechia

Site Status

1245.24.420102 Boehringer Ingelheim Investigational Site

Hodonín, , Czechia

Site Status

1245.24.372101 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1245.24.372102 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1245.24.372103 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1245.24.372104 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1245.24.372105 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

Site Status

1245.24.581006 Boehringer Ingelheim Investigational Site

Kerava, , Finland

Site Status

1245.24.581003 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

1245.24.581004 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1245.24.581001 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1245.24.3302A Boehringer Ingelheim Investigational Site

Bondy, , France

Site Status

1245.24.3302B Boehringer Ingelheim Investigational Site

Bondy, , France

Site Status

1245.24.3310A Boehringer Ingelheim Investigational Site

Caen, , France

Site Status

1245.24.3310C Boehringer Ingelheim Investigational Site

Caen, , France

Site Status

1245.24.3301A Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, , France

Site Status

1245.24.3303A Boehringer Ingelheim Investigational Site

La Rochelle, , France

Site Status

1245.24.3303B Boehringer Ingelheim Investigational Site

La Rochelle, , France

Site Status

1245.24.3309A Boehringer Ingelheim Investigational Site

Nanterre, , France

Site Status

1245.24.3306A Boehringer Ingelheim Investigational Site

Narbonne, , France

Site Status

1245.24.3304A Boehringer Ingelheim Investigational Site

Reims, , France

Site Status

1245.24.3311B Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

Site Status

1245.24.3305A Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.24.3305B Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.24.491011 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1245.24.491007 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

1245.24.491004 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1245.24.491005 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1245.24.491002 Boehringer Ingelheim Investigational Site

Melsungen, , Germany

Site Status

1245.24.491012 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1245.24.491008 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

1245.24.491003 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, , Germany

Site Status

1245.24.491010 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, , Germany

Site Status

1245.24.361001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1245.24.361003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1245.24.361004 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1245.24.361005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

1245.24.361002 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

Site Status

1245.24.391006 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1245.24.391003 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1245.24.391005 Boehringer Ingelheim Investigational Site

Treviso, , Italy

Site Status

1245.24.371101 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

Site Status

1245.24.371105 Boehringer Ingelheim Investigational Site

Kuldīga, , Latvia

Site Status

1245.24.371106 Boehringer Ingelheim Investigational Site

Ogre, , Latvia

Site Status

1245.24.371103 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1245.24.371107 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1245.24.371102 Boehringer Ingelheim Investigational Site

Talsi, , Latvia

Site Status

1245.24.371104 Boehringer Ingelheim Investigational Site

Valmiera, , Latvia

Site Status

1245.24.370102 Boehringer Ingelheim Investigational Site

Klaipėda, , Lithuania

Site Status

1245.24.370101 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

Site Status

1245.24.471004 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

Site Status

1245.24.471003 Boehringer Ingelheim Investigational Site

Hamar, , Norway

Site Status

1245.24.471005 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1245.24.471001 Boehringer Ingelheim Investigational Site

Stavanger, , Norway

Site Status

1245.24.401005 Boehringer Ingelheim Investigational Site

Alba Iulia, , Romania

Site Status

1245.24.401006 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, , Romania

Site Status

1245.24.401002 Boehringer Ingelheim Investigational Site

Brasov, , Romania

Site Status

1245.24.401001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1245.24.401008 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1245.24.401003 Boehringer Ingelheim Investigational Site

Galati, , Romania

Site Status

1245.24.401007 Boehringer Ingelheim Investigational Site

Satu Mare, , Romania

Site Status

1245.24.401004 Boehringer Ingelheim Investigational Site

Târgu Mureş, , Romania

Site Status

1245.24.701002 Boehringer Ingelheim Investigational Site

Kazan', , Russia

Site Status

1245.24.701008 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1245.24.701009 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1245.24.701010 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1245.24.701004 Boehringer Ingelheim Investigational Site

Petrozavodsk, , Russia

Site Status

1245.24.701012 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1245.24.701013 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1245.24.701014 Boehringer Ingelheim Investigational Site

Saratov, , Russia

Site Status

1245.24.701005 Boehringer Ingelheim Investigational Site

Smolensk, , Russia

Site Status

1245.24.701006 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1245.24.701007 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1245.24.701001 Boehringer Ingelheim Investigational Site

Yekaterinburg, , Russia

Site Status

1245.24.421102 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1245.24.421107 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1245.24.421103 Boehringer Ingelheim Investigational Site

Lučenec, , Slovakia

Site Status

1245.24.421105 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.24.421106 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.24.421104 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, , Slovakia

Site Status

1245.24.421108 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

1245.24.421101 Boehringer Ingelheim Investigational Site

Prievidza, , Slovakia

Site Status

1245.24.821006 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1245.24.821008 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1245.24.821007 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1245.24.821002 Boehringer Ingelheim Investigational Site

Pucheon, , South Korea

Site Status

1245.24.821001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.24.821004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.24.821009 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1245.24.821003 Boehringer Ingelheim Investigational Site

Uijeongbu-si, , South Korea

Site Status

1245.24.341002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1245.24.341001 Boehringer Ingelheim Investigational Site

Girona, , Spain

Site Status

1245.24.341010 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

Site Status

1245.24.341004 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1245.24.341005 Boehringer Ingelheim Investigational Site

Palma Mallorca, , Spain

Site Status

1245.24.341006 Boehringer Ingelheim Investigational Site

Palma Mallorca, , Spain

Site Status

1245.24.341008 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1245.24.461004 Boehringer Ingelheim Investigational Site

Härnösand, , Sweden

Site Status

1245.24.461005 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1245.24.461001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1245.24.886105 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1245.24.886107 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1245.24.886104 Boehringer Ingelheim Investigational Site

Taichun, , Taiwan

Site Status

1245.24.886106 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1245.24.886101 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.24.886103 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.24.886102 Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Site Status

1245.24.381007 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1245.24.381003 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.24.381009 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.24.381010 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.24.381008 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1245.24.381002 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1245.24.381006 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1245.24.381001 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

Site Status

1245.24.381005 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

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United States Austria Croatia Czechia Estonia Finland France Germany Hungary Italy Latvia Lithuania Norway Romania Russia Slovakia South Korea Spain Sweden Taiwan Ukraine

References

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Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

Reference Type DERIVED
PMID: 24186878 (View on PubMed)

Other Identifiers

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2008-007938-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.24

Identifier Type: -

Identifier Source: org_study_id

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