Clinical trial NCT00881530: Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hypoglycaemic Events
timeFrame: 78 weeks plus 1 week of follow-up
measure: Change From Baseline to Week 78 in Lipid Parameters
timeFrame: Weeks 1 and 78
measure: Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
timeFrame: 78 weeks plus 1 week of follow-up
Secondary outcomes:
measure: Change From Baseline in HbA1c Over Time
timeFrame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
measure: Occurence of a Treat-to-target Response (HbA1c < 7.0%)
timeFrame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
measure: Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
timeFrame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
measure: Occurrence of a Relative Efficacy Response
timeFrame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
timeFrame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: 1245.24.101001 Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: 1245.24.101028 Boehringer Ingelheim Investigational Site
state: California
city: Walnut Creek
country: United States
facility: 1245.24.101027 Boehringer Ingelheim Investigational Site
state: California
city: Clearwarter
country: United States
facility: 1245.24.101004 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1245.24.101005 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Cloud
country: United States
facility: 1245.24.101024 Boehringer Ingelheim Investigational Site
state: Florida
city: Roswell
country: United States
facility: 1245.24.101014 Boehringer Ingelheim Investigational Site
state: Georgia
city: Staten Island
country: United States
facility: 1245.24.101016 Boehringer Ingelheim Investigational Site
state: New York
city: Wadsworth
country: United States
facility: 1245.24.101006 Boehringer Ingelheim Investigational Site
state: Ohio
city: Norristown
country: United States
facility: 1245.24.101023 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: 1245.24.101015 Boehringer Ingelheim Investigational Site
state: Texas
city: Federal Way
country: United States
facility: 1245.24.101025 Boehringer Ingelheim Investigational Site
state: Washington
city: Graz
country: Austria
facility: 1245.24.431002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.24.431001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1245.24.431003 Boehringer Ingelheim Investigational Site
city: Karlovac
country: Croatia
facility: 1245.24.385104 Boehringer Ingelheim Investigational Site
city: Krapinske Toplice
country: Croatia
facility: 1245.24.385103 Boehringer Ingelheim Investigational Site
city: Osijek
country: Croatia
facility: 1245.24.385106 Boehringer Ingelheim Investigational Site
city: Zagreb
country: Croatia
facility: 1245.24.385101 Boehringer Ingelheim Investigational Site
city: Breclav
country: Czech Republic
facility: 1245.24.420101 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.24.420103 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1245.24.420105 Boehringer Ingelheim Investigational Site
city: Hodonin
country: Czech Republic
facility: 1245.24.420102 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.24.372101 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.24.372102 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.24.372103 Boehringer Ingelheim Investigational Site
city: Tallinn
country: Estonia
facility: 1245.24.372104 Boehringer Ingelheim Investigational Site
city: Tartu
country: Estonia
facility: 1245.24.372105 Boehringer Ingelheim Investigational Site
city: Kerava
country: Finland
facility: 1245.24.581006 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1245.24.581003 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 1245.24.581004 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1245.24.581001 Boehringer Ingelheim Investigational Site
city: Bondy Cedex
country: France
facility: 1245.24.3302A Boehringer Ingelheim Investigational Site
city: Bondy Cedex
country: France
facility: 1245.24.3302B Boehringer Ingelheim Investigational Site
city: Caen Cedex 5
country: France
facility: 1245.24.3310A Boehringer Ingelheim Investigational Site
city: Caen Cedex 5
country: France
facility: 1245.24.3310C Boehringer Ingelheim Investigational Site
city: Corbeil Essonnes
country: France
facility: 1245.24.3301A Boehringer Ingelheim Investigational Site
city: La Rochelle Cedex 1
country: France
facility: 1245.24.3303A Boehringer Ingelheim Investigational Site
city: La Rochelle Cedex 1
country: France
facility: 1245.24.3303B Boehringer Ingelheim Investigational Site
city: Nanterre Cedex
country: France
facility: 1245.24.3309A Boehringer Ingelheim Investigational Site
city: Narbonne Cedex
country: France
facility: 1245.24.3306A Boehringer Ingelheim Investigational Site
city: Reims Cedex
country: France
facility: 1245.24.3304A Boehringer Ingelheim Investigational Site
city: Saint Mandé
country: France
facility: 1245.24.3311B Boehringer Ingelheim Investigational Site
city: Valenciennes
country: France
facility: 1245.24.3305A Boehringer Ingelheim Investigational Site
city: Valenciennes
country: France
facility: 1245.24.3305B Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1245.24.491011 Boehringer Ingelheim Investigational Site
city: Frankfurt am Main
country: Germany
facility: 1245.24.491007 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1245.24.491004 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1245.24.491005 Boehringer Ingelheim Investigational Site
city: Melsungen
country: Germany
facility: 1245.24.491002 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1245.24.491012 Boehringer Ingelheim Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: 1245.24.491008 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1245.24.491003 Boehringer Ingelheim Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: 1245.24.491010 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1245.24.361001 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1245.24.361003 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1245.24.361004 Boehringer Ingelheim Investigational Site
city: Gyor
country: Hungary
facility: 1245.24.361005 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1245.24.361002 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1245.24.391006 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1245.24.391003 Boehringer Ingelheim Investigational Site
city: Treviso
country: Italy
facility: 1245.24.391005 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1245.24.821006 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1245.24.821008 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1245.24.821007 Boehringer Ingelheim Investigational Site
city: Pucheon
country: Korea, Republic of
facility: 1245.24.821002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.24.821001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.24.821004 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1245.24.821009 Boehringer Ingelheim Investigational Site
city: Uijeongbu
country: Korea, Republic of
facility: 1245.24.821003 Boehringer Ingelheim Investigational Site
city: Daugavpils
country: Latvia
facility: 1245.24.371101 Boehringer Ingelheim Investigational Site
city: Kuldiga
country: Latvia
facility: 1245.24.371105 Boehringer Ingelheim Investigational Site
city: Ogre
country: Latvia
facility: 1245.24.371106 Boehringer Ingelheim Investigational Site
city: Riga
country: Latvia
facility: 1245.24.371103 Boehringer Ingelheim Investigational Site
city: Riga
country: Latvia
facility: 1245.24.371107 Boehringer Ingelheim Investigational Site
city: Talsi
country: Latvia
facility: 1245.24.371102 Boehringer Ingelheim Investigational Site
city: Valmiera
country: Latvia
facility: 1245.24.371104 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 1245.24.370102 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 1245.24.370101 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1245.24.471003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1245.24.471005 Boehringer Ingelheim Investigational Site
city: Stavanger
country: Norway
facility: 1245.24.471001 Boehringer Ingelheim Investigational Site
city: Ålesund
country: Norway
facility: 1245.24.471004 Boehringer Ingelheim Investigational Site
city: Alba Iulia
country: Romania
facility: 1245.24.401005 Boehringer Ingelheim Investigational Site
city: Baia Mare Maramures
country: Romania
facility: 1245.24.401006 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1245.24.401002 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1245.24.401001 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1245.24.401008 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1245.24.401003 Boehringer Ingelheim Investigational Site
city: Satu Mare
country: Romania
facility: 1245.24.401007 Boehringer Ingelheim Investigational Site
city: Targu-Mures
country: Romania
facility: 1245.24.401004 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 1245.24.701001 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1245.24.701002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.24.701008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.24.701009 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1245.24.701010 Boehringer Ingelheim Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: 1245.24.701004 Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: 1245.24.701014 Boehringer Ingelheim Investigational Site
city: Smolensk
country: Russian Federation
facility: 1245.24.701005 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.24.701012 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1245.24.701013 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1245.24.701006 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1245.24.701007 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1245.24.421102 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1245.24.421107 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1245.24.421103 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1245.24.421105 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1245.24.421106 Boehringer Ingelheim Investigational Site
city: Nove Mesto Nad Vahom
country: Slovakia
facility: 1245.24.421104 Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: 1245.24.421108 Boehringer Ingelheim Investigational Site
city: Prievidza
country: Slovakia
facility: 1245.24.421101 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1245.24.341002 Boehringer Ingelheim Investigational Site
city: Girona
country: Spain
facility: 1245.24.341001 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat (Barcelona)
country: Spain
facility: 1245.24.341010 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1245.24.341004 Boehringer Ingelheim Investigational Site
city: Palma Mallorca
country: Spain
facility: 1245.24.341005 Boehringer Ingelheim Investigational Site
city: Palma Mallorca
country: Spain
facility: 1245.24.341006 Boehringer Ingelheim Investigational Site
city: Santander
country: Spain
facility: 1245.24.341008 Boehringer Ingelheim Investigational Site
city: Härnösand
country: Sweden
facility: 1245.24.461004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1245.24.461005 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.24.461001 Boehringer Ingelheim Investigational Site
city: Changhua
country: Taiwan
facility: 1245.24.886105 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.24.886107 Boehringer Ingelheim Investigational Site
city: Taichun
country: Taiwan
facility: 1245.24.886104 Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: 1245.24.886106 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.24.886101 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.24.886103 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 1245.24.886102 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1245.24.381007 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1245.24.381010 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1245.24.381003 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1245.24.381009 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1245.24.381008 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1245.24.381002 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1245.24.381006 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 1245.24.381001 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 1245.24.381005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.