| Outcome Measures: |
Primary: Hypoglycaemic Events, 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, 78 weeks plus 1 week of follow-up|Change From Baseline to Week 78 in Lipid Parameters, Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride), Weeks 1 and 78|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements, 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., 78 weeks plus 1 week of follow-up | Secondary: Change From Baseline in HbA1c Over Time, Baseline source: before first intake of active treatment (preceding trial or Open label extension), Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Occurence of a Treat-to-target Response (HbA1c < 7.0%), Occurence of a treat-to-target response, defined as HbA1c \< 7.0% over time, Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Occurrence of a Treat-to-target Response (HbA1c < 6.5%), Occurrence of a Treat-to-target Response, defined as HbA1c \< 6.5% over time, Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Occurrence of a Relative Efficacy Response, Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least \>=0.5% over time), Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Change From Baseline in Fasting Plasma Glucose (FPG) Over Time, Baseline source: before first intake of active treatment (preceding trial or Open label extension), Weeks 1, 6, 18, 30, 42, 54, 66 and 78
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| Locations: |
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|1245.24.431001 Boehringer Ingelheim Investigational Site, Wien, Austria|1245.24.431003 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|1245.24.372101 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.24.372102 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.24.372103 Boehringer Ingelheim Investigational Site, Tallinn, Estonia|1245.24.372104 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|1245.24.3302A Boehringer Ingelheim Investigational Site, Bondy Cedex, France|1245.24.3302B Boehringer Ingelheim Investigational Site, Bondy Cedex, France|1245.24.3310A Boehringer Ingelheim Investigational Site, Caen Cedex 5, France|1245.24.3310C 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|1245.24.3305A Boehringer Ingelheim Investigational Site, Valenciennes, France|1245.24.3305B 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|1245.24.491004 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1245.24.491005 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|1245.24.361001 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1245.24.361003 Boehringer Ingelheim Investigational Site, Budapest, Hungary|1245.24.361004 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|1245.24.821006 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1245.24.821008 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|1245.24.821001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.24.821004 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|1245.24.371103 Boehringer Ingelheim Investigational Site, Riga, Latvia|1245.24.371107 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|1245.24.401001 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1245.24.401008 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|1245.24.701009 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation|1245.24.701010 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|1245.24.701012 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation|1245.24.701013 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|1245.24.421102 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1245.24.421107 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1245.24.421103 Boehringer Ingelheim Investigational Site, Lucenec, Slovakia|1245.24.421105 Boehringer Ingelheim Investigational Site, Nitra, Slovakia|1245.24.421106 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|1245.24.886101 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.24.886103 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|1245.24.381003 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1245.24.381009 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
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