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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: BI 10773
Drug: Metformin
Drug: BI 10773
Drug: Sitagliptin
PhasePhase 2
SponsorBoehringer Ingelheim
Responsible PartyBoehringer Ingelheim
ClinicalTrials.gov IdentifierNCT00881530
First ReceivedApril 14, 2009
Last UpdatedSeptember 27, 2012
Last verifiedSeptember 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 14, 2009
Last Updated DateSeptember 27, 2012
Start DateMarch 2009
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measures
  • Primary endpoints are all safety relevant parameters: [Time Frame: 78 weeks] [Designated as safety issue: No]
  • incidence of adverse events; incidence of hypoglycemic events; use of rescue therapy; change from baseline in vital signs, body weight, waist circumference, lipid parameters to week 78; significant changes from baseline in clinical laboratory [Time Frame: 78 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change in HbA1c from baseline (over time and after 78 weeks) [Time Frame: 78 weeks] [Designated as safety issue: No]
  • percentage of patients treated to target HbA1c < 7.0 [Time Frame: 78 weeks] [Designated as safety issue: No]
  • Change in fasting plasma glucose (over time and after 78 weeks) [Time Frame: 78 weeks] [Designated as safety issue: No]
  • occurence of an additional treat to target response, defined as an HbA1c after 78 weeks of <6.5% [Time Frame: 78 weeks] [Designated as safety issue: No]
  • occurence of a relative efficacy response (HbA1c lowered by >=0.5% after 78 weeks of treatment) [Time Frame: 78 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEmpagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: 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)
  • Active Comparator: Sitagliptin
    100 mg
  • Active Comparator: Metformin
    2000 mg
  • Experimental: BI 10773 X mg
    lower dose
  • Experimental: BI 10773 Y mg
    higher dose

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment660
Estimated Completion DateNot Provided
Estimated Primary Completion DateMay 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited 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
Other Study ID Numbers1245.24
Has Data Monitoring CommitteeNot Provided
Information Provided ByBoehringer Ingelheim
Study SponsorBoehringer Ingelheim
CollaboratorsNot Provided
Investigators Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification DateSeptember 2012

Locations[ + expand ][ + ]

1245.24.101001 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
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