| Outcome Measures: |
Primary: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment, Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups., Baseline and 12 weeks | Secondary: Change of FPG From Baseline After 12 Weeks of Treatment, Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups., Baseline and 12 weeks|Change of HbA1c From Baseline Over Time, Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis., Baseline and weeks 4, 8 and 12|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment, Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%)., 12 weeks|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment, Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%)., 12 weeks|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI), Results for change of FPI from baseline at week 12 based on ANCOVA., Baseline and 12 weeks|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR), HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA., Baseline and 12 weeks|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B), HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA., Baseline and 12 weeks|Change of Body Weight After 12 Weeks of Treatment, Results for change of body weight after 12 weeks of treatment based on ANCOVA., Baseline and 12 weeks|Trough Concentrations of Empagliflozin in Plasma, Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma, Days 28, 56 and 84
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| Locations: |
1245.9.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54007 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54008 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54009 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54010 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina|1245.9.54004 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina|1245.9.54003 Boehringer Ingelheim Investigational Site, Mendoza, Argentina|1245.9.54005 Boehringer Ingelheim Investigational Site, Salta, Argentina|1245.9.54006 Boehringer Ingelheim Investigational Site, Salta, Argentina|1245.9.38504 Boehringer Ingelheim Investigational Site, Karlovac, Croatia|1245.9.38503 Boehringer Ingelheim Investigational Site, Krapinske Toplice, Croatia|1245.9.38506 Boehringer Ingelheim Investigational Site, Osijek, Croatia|1245.9.38505 Boehringer Ingelheim Investigational Site, Varazdin, Croatia|1245.9.38501 Boehringer Ingelheim Investigational Site, Zagreb, Croatia|1245.9.37201 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1245.9.37202 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1245.9.37203 Boehringer Ingelheim Investigational Site, Tallin, Estonia|1245.9.49007 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany|1245.9.49001 Boehringer Ingelheim Investigational Site, Erlangen, Germany|1245.9.49004 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1245.9.49005 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1245.9.49002 Boehringer Ingelheim Investigational Site, Melsungen, Germany|1245.9.49008 Boehringer Ingelheim Investigational Site, Nürnberg, Germany|1245.9.49003 Boehringer Ingelheim Investigational Site, St. Ingbert/Oberwürzbach, Germany|1245.9.49006 Boehringer Ingelheim Investigational Site, Sulzbach-Rosenberg, Germany|1245.9.39006 Boehringer Ingelheim Investigational Site, Genova, Italy|1245.9.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy|1245.9.39003 Boehringer Ingelheim Investigational Site, Pisa, Italy|1245.9.39004 Boehringer Ingelheim Investigational Site, Siena, Italy|1245.9.39005 Boehringer Ingelheim Investigational Site, Treviso, Italy|1245.9.82006 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1245.9.82008 Boehringer Ingelheim Investigational Site, Goyang, Korea, Republic of|1245.9.82007 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of|1245.9.82002 Boehringer Ingelheim Investigational Site, Pucheon, Korea, Republic of|1245.9.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.9.82004 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.9.82005 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of|1245.9.82009 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of|1245.9.82003 Boehringer Ingelheim Investigational Site, Uijeongbu, Korea, Republic of|1245.9.37002 Boehringer Ingelheim Investigational Site, Klaipeda, Lithuania|1245.9.37001 Boehringer Ingelheim Investigational Site, Vilnius, Lithuania|1245.9.40003 Boehringer Ingelheim Investigational Site, Brasov, Romania|1245.9.40002 Boehringer Ingelheim Investigational Site, Bucharest, Romania|1245.9.40004 Boehringer Ingelheim Investigational Site, Galati, Romania|1245.9.40005 Boehringer Ingelheim Investigational Site, Targu-Mures, Romania|1245.9.70001 Boehringer Ingelheim Investigational Site, Ekaterinburg, Russian Federation|1245.9.70002 Boehringer Ingelheim Investigational Site, Kazan, Russian Federation|1245.9.70003 Boehringer Ingelheim Investigational Site, Nizhniy Novgorod, Russian Federation|1245.9.70004 Boehringer Ingelheim Investigational Site, Petrozavodsk, Russian Federation|1245.9.70005 Boehringer Ingelheim Investigational Site, Smolensk, Russian Federation|1245.9.70006 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1245.9.70007 Boehringer Ingelheim Investigational Site, Yaroslavl, Russian Federation|1245.9.62002 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia|1245.9.62003 Boehringer Ingelheim Investigational Site, Lucenec, Slovakia|1245.9.62004 Boehringer Ingelheim Investigational Site, Nove Mesto Nad Vahom, Slovakia|1245.9.62001 Boehringer Ingelheim Investigational Site, Prievidza, Slovakia|1245.9.46003 Boehringer Ingelheim Investigational Site, Göteborg, Sweden|1245.9.46004 Boehringer Ingelheim Investigational Site, Härnösand, Sweden|1245.9.46005 Boehringer Ingelheim Investigational Site, Lund, Sweden|1245.9.46001 Boehringer Ingelheim Investigational Site, Stockholm, Sweden|1245.9.46002 Boehringer Ingelheim Investigational Site, Västerås, Sweden|1245.9.88605 Boehringer Ingelheim Investigational Site, Changhua, Taiwan|1245.9.88607 Boehringer Ingelheim Investigational Site, Kaohsiung, Taiwan|1245.9.88604 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1245.9.88606 Boehringer Ingelheim Investigational Site, Tainan, Taiwan|1245.9.88601 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.9.88603 Boehringer Ingelheim Investigational Site, Taipei, Taiwan|1245.9.88602 Boehringer Ingelheim Investigational Site, Taoyuan, Taiwan|1245.9.38003 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine|1245.9.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine|1245.9.38002 Boehringer Ingelheim Investigational Site, Odessa, Ukraine|1245.9.38001 Boehringer Ingelheim Investigational Site, Vinnytsya, Ukraine|1245.9.38005 Boehringer Ingelheim Investigational Site, Vinnytsya, Ukraine
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