Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00881530
- Lead Sponsor
- Boehringer Ingelheim
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 10773 X mg BI 10773 lower dose BI 10773 Y mg BI 10773 higher dose Metformin Metformin 2000 mg Sitagliptin Sitagliptin 100 mg
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 78 in Lipid Parameters Weeks 1 and 78 Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements 78 weeks plus 1 week of follow-up Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.
Hypoglycaemic Events 78 weeks plus 1 week of follow-up Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:
* Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)
* Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)
* Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance
* Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
- Secondary Outcome Measures
Name Time Method Occurence of a Treat-to-target Response (HbA1c < 7.0%) Weeks 1, 6, 18, 30, 42, 54, 66 and 78 Occurence of a treat-to-target response, defined as HbA1c \< 7.0% over time
Change From Baseline in HbA1c Over Time Weeks 1, 6, 18, 30, 42, 54, 66 and 78 Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Occurrence of a Treat-to-target Response (HbA1c < 6.5%) Weeks 1, 6, 18, 30, 42, 54, 66 and 78 Occurrence of a Treat-to-target Response, defined as HbA1c \< 6.5% over time
Occurrence of a Relative Efficacy Response Weeks 1, 6, 18, 30, 42, 54, 66 and 78 Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least \>=0.5% over time)
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Weeks 1, 6, 18, 30, 42, 54, 66 and 78 Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Trial Locations
- Locations (137)
1245.24.101006 Boehringer Ingelheim Investigational Site
🇺🇸Wadsworth, Ohio, United States
1245.24.101024 Boehringer Ingelheim Investigational Site
🇺🇸St. Cloud, Florida, United States
1245.24.101015 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1245.24.431002 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1245.24.3310A Boehringer Ingelheim Investigational Site
🇫🇷Caen Cedex 5, France
1245.24.491011 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1245.24.101014 Boehringer Ingelheim Investigational Site
🇺🇸Roswell, Georgia, United States
1245.24.101016 Boehringer Ingelheim Investigational Site
🇺🇸Staten Island, New York, United States
1245.24.3302A Boehringer Ingelheim Investigational Site
🇫🇷Bondy Cedex, France
1245.24.3310C Boehringer Ingelheim Investigational Site
🇫🇷Caen Cedex 5, France
1245.24.101001 Boehringer Ingelheim Investigational Site
🇺🇸Mission Viejo, California, United States
1245.24.491002 Boehringer Ingelheim Investigational Site
🇩🇪Melsungen, Germany
1245.24.372102 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1245.24.372105 Boehringer Ingelheim Investigational Site
🇪🇪Tartu, Estonia
1245.24.491004 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1245.24.101023 Boehringer Ingelheim Investigational Site
🇺🇸Norristown, Pennsylvania, United States
1245.24.3302B Boehringer Ingelheim Investigational Site
🇫🇷Bondy Cedex, France
1245.24.341010 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1245.24.821003 Boehringer Ingelheim Investigational Site
🇰🇷Uijeongbu, Korea, Republic of
1245.24.372104 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1245.24.371103 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
1245.24.391003 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1245.24.3303B Boehringer Ingelheim Investigational Site
🇫🇷La Rochelle Cedex 1, France
1245.24.3305A Boehringer Ingelheim Investigational Site
🇫🇷Valenciennes, France
1245.24.491012 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1245.24.361005 Boehringer Ingelheim Investigational Site
🇭🇺Gyor, Hungary
1245.24.371101 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
1245.24.491005 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1245.24.370101 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
1245.24.401002 Boehringer Ingelheim Investigational Site
🇷🇴Brasov, Romania
1245.24.821001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.24.491008 Boehringer Ingelheim Investigational Site
🇩🇪Rehlingen-Siersburg, Germany
1245.24.491007 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt am Main, Germany
1245.24.821004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1245.24.361002 Boehringer Ingelheim Investigational Site
🇭🇺Szombathely, Hungary
1245.24.371105 Boehringer Ingelheim Investigational Site
🇱🇻Kuldiga, Latvia
1245.24.391005 Boehringer Ingelheim Investigational Site
🇮🇹Treviso, Italy
1245.24.821007 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1245.24.371102 Boehringer Ingelheim Investigational Site
🇱🇻Talsi, Latvia
1245.24.401006 Boehringer Ingelheim Investigational Site
🇷🇴Baia Mare Maramures, Romania
1245.24.401007 Boehringer Ingelheim Investigational Site
🇷🇴Satu Mare, Romania
1245.24.421103 Boehringer Ingelheim Investigational Site
🇸🇰Lucenec, Slovakia
1245.24.821006 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1245.24.491010 Boehringer Ingelheim Investigational Site
🇩🇪Sulzbach-Rosenberg, Germany
1245.24.361003 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1245.24.701010 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.24.471001 Boehringer Ingelheim Investigational Site
🇳🇴Stavanger, Norway
1245.24.401003 Boehringer Ingelheim Investigational Site
🇷🇴Galati, Romania
1245.24.701013 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.24.341006 Boehringer Ingelheim Investigational Site
🇪🇸Palma Mallorca, Spain
1245.24.701006 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1245.24.421102 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1245.24.421105 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1245.24.381008 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1245.24.391006 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1245.24.421104 Boehringer Ingelheim Investigational Site
🇸🇰Nove Mesto Nad Vahom, Slovakia
1245.24.886105 Boehringer Ingelheim Investigational Site
🇨🇳Changhua, Taiwan
1245.24.886106 Boehringer Ingelheim Investigational Site
🇨🇳Tainan, Taiwan
1245.24.381003 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1245.24.341001 Boehringer Ingelheim Investigational Site
🇪🇸Girona, Spain
1245.24.421101 Boehringer Ingelheim Investigational Site
🇸🇰Prievidza, Slovakia
1245.24.886104 Boehringer Ingelheim Investigational Site
🇨🇳Taichun, Taiwan
1245.24.381010 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1245.24.381001 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
1245.24.461004 Boehringer Ingelheim Investigational Site
🇸🇪Härnösand, Sweden
1245.24.461001 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1245.24.341002 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1245.24.341005 Boehringer Ingelheim Investigational Site
🇪🇸Palma Mallorca, Spain
1245.24.381007 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1245.24.381006 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine
1245.24.381005 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
1245.24.886107 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1245.24.886102 Boehringer Ingelheim Investigational Site
🇨🇳Taoyuan, Taiwan
1245.24.886103 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1245.24.101005 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1245.24.101004 Boehringer Ingelheim Investigational Site
🇺🇸Clearwarter, Florida, United States
1245.24.101027 Boehringer Ingelheim Investigational Site
🇺🇸Walnut Creek, California, United States
1245.24.101028 Boehringer Ingelheim Investigational Site
🇺🇸Spring Valley, California, United States
1245.24.431001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1245.24.101025 Boehringer Ingelheim Investigational Site
🇺🇸Federal Way, Washington, United States
1245.24.420105 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1245.24.3301A Boehringer Ingelheim Investigational Site
🇫🇷Corbeil Essonnes, France
1245.24.491003 Boehringer Ingelheim Investigational Site
🇩🇪St. Ingbert/Oberwürzbach, Germany
1245.24.821008 Boehringer Ingelheim Investigational Site
🇰🇷Goyang, Korea, Republic of
1245.24.370102 Boehringer Ingelheim Investigational Site
🇱🇹Klaipeda, Lithuania
1245.24.701004 Boehringer Ingelheim Investigational Site
🇷🇺Petrozavodsk, Russian Federation
1245.24.701009 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.24.701001 Boehringer Ingelheim Investigational Site
🇷🇺Ekaterinburg, Russian Federation
1245.24.701014 Boehringer Ingelheim Investigational Site
🇷🇺Saratov, Russian Federation
1245.24.421108 Boehringer Ingelheim Investigational Site
🇸🇰Presov, Slovakia
1245.24.421106 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
1245.24.341004 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1245.24.886101 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1245.24.461005 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1245.24.3303A 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
1245.24.341008 Boehringer Ingelheim Investigational Site
🇪🇸Santander, Spain
1245.24.821009 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
1245.24.821002 Boehringer Ingelheim Investigational Site
🇰🇷Pucheon, Korea, Republic of
1245.24.420103 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1245.24.372103 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1245.24.581006 Boehringer Ingelheim Investigational Site
🇫🇮Kerava, Finland
1245.24.581004 Boehringer Ingelheim Investigational Site
🇫🇮Tampere, Finland
1245.24.371107 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
1245.24.401005 Boehringer Ingelheim Investigational Site
🇷🇴Alba Iulia, Romania
1245.24.701012 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1245.24.421107 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1245.24.361001 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
1245.24.471004 Boehringer Ingelheim Investigational Site
🇳🇴Ålesund, Norway
1245.24.401001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1245.24.701002 Boehringer Ingelheim Investigational Site
🇷🇺Kazan, Russian Federation
1245.24.381002 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1245.24.701007 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1245.24.385104 Boehringer Ingelheim Investigational Site
🇭🇷Karlovac, Croatia
1245.24.385101 Boehringer Ingelheim Investigational Site
🇭🇷Zagreb, Croatia
1245.24.420102 Boehringer Ingelheim Investigational Site
🇨🇿Hodonin, Czech Republic
1245.24.401008 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1245.24.401004 Boehringer Ingelheim Investigational Site
🇷🇴Targu-Mures, Romania
1245.24.385103 Boehringer Ingelheim Investigational Site
🇭🇷Krapinske Toplice, Croatia
1245.24.581001 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1245.24.385106 Boehringer Ingelheim Investigational Site
🇭🇷Osijek, Croatia
1245.24.372101 Boehringer Ingelheim Investigational Site
🇪🇪Tallinn, Estonia
1245.24.581003 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1245.24.371104 Boehringer Ingelheim Investigational Site
🇱🇻Valmiera, Latvia
1245.24.471003 Boehringer Ingelheim Investigational Site
🇳🇴Hamar, Norway
1245.24.471005 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1245.24.431003 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1245.24.420101 Boehringer Ingelheim Investigational Site
🇨🇿Breclav, Czech Republic
1245.24.371106 Boehringer Ingelheim Investigational Site
🇱🇻Ogre, Latvia
1245.24.381009 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1245.24.701005 Boehringer Ingelheim Investigational Site
🇷🇺Smolensk, Russian Federation
1245.24.701008 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1245.24.361004 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary