| Outcome Measures: |
Primary: The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group, The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group., Baseline and week 24|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC), The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered. The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week. The sensitivity analysis was added as the primary analysis failed with borderline results., Baseline and week 24|The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG, The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG) The mean was adjusted by baseline HbA1c and treatment group., Baseline and week 12 | Secondary: The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group, The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 24 weeks of treatment in main group., Week 24 (after first drug administration)|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG, The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 12 weeks of treatment in APG., Week 12 (after first drug administration)|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group, The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 24 weeks of treatment in main group., Week 24 (after first drug administration)|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG, The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 12 weeks of treatment in APG., Week 12 (after first drug administration)|The Occurrence of Relative Efficacy Response in Main Group, The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group, From baseline until week 24|The Occurrence of Relative Efficacy Response in APG, The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG, From baseline until week 12|The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group, The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group., Baseline and week 24|The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG, The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group., Baseline and week 12|The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group, The frequency of patients with use of rescue therapy during 24 week treatment period in main group. For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group., From baseline until week 24|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG, The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG., From baseline until week 12
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| Locations: |
1288.18.86001 Boehringer Ingelheim Investigational Site, Beijing, China|1288.18.86002 Boehringer Ingelheim Investigational Site, Beijing, China|1288.18.86003 Boehringer Ingelheim Investigational Site, Beijing, China|1288.18.86004 Boehringer Ingelheim Investigational Site, Beijing, China|1288.18.86046 Boehringer Ingelheim Investigational Site, Beijing, China|1288.18.86019 Boehringer Ingelheim Investigational Site, Changchun, China|1288.18.86020 Boehringer Ingelheim Investigational Site, Changchun, China|1288.18.86028 Boehringer Ingelheim Investigational Site, Changsha, China|1288.18.86029 Boehringer Ingelheim Investigational Site, Changsha, China|1288.18.86050 Boehringer Ingelheim Investigational Site, Changsha, China|1288.18.86045 Boehringer Ingelheim Investigational Site, Chengdu, China|1288.18.86042 Boehringer Ingelheim Investigational Site, Chongqing, China|1288.18.86023 Boehringer Ingelheim Investigational Site, Dalian, China|1288.18.86009 Boehringer Ingelheim Investigational Site, Guangzhou, China|1288.18.86010 Boehringer Ingelheim Investigational Site, Guangzhou, China|1288.18.86012 Boehringer Ingelheim Investigational Site, Guangzhou, China|1288.18.86047 Boehringer Ingelheim Investigational Site, Haerbin, China|1288.18.86032 Boehringer Ingelheim Investigational Site, Hefei, China|1288.18.86016 Boehringer Ingelheim Investigational Site, Hengshui, China|1288.18.86017 Boehringer Ingelheim Investigational Site, Jinan, China|1288.18.86026 Boehringer Ingelheim Investigational Site, Lanzhou, China|1288.18.86034 Boehringer Ingelheim Investigational Site, Nan Ning, China|1288.18.86039 Boehringer Ingelheim Investigational Site, Nanchang, China|1288.18.86035 Boehringer Ingelheim Investigational Site, Nanjing, China|1288.18.86036 Boehringer Ingelheim Investigational Site, Nanjing, China|1288.18.86006 Boehringer Ingelheim Investigational Site, Shanghai, China|1288.18.86007 Boehringer Ingelheim Investigational Site, Shanghai, China|1288.18.86008 Boehringer Ingelheim Investigational Site, Shanghai, China|1288.18.86013 Boehringer Ingelheim Investigational Site, Shantou, China|1288.18.86022 Boehringer Ingelheim Investigational Site, Shenyang, China|1288.18.86014 Boehringer Ingelheim Investigational Site, Shijiazhuang, China|1288.18.86015 Boehringer Ingelheim Investigational Site, Shijiazhuang, China|1288.18.86038 Boehringer Ingelheim Investigational Site, Suzhou, China|1288.18.86049 Boehringer Ingelheim Investigational Site, Wuhan, China|1288.18.86033 Boehringer Ingelheim Investigational Site, Wuhu, China|1288.18.86024 Boehringer Ingelheim Investigational Site, Xi'An, China|1288.18.86025 Boehringer Ingelheim Investigational Site, Xi'An, China|1288.18.86030 Boehringer Ingelheim Investigational Site, Yueyang, China|1288.18.60004 Boehringer Ingelheim Investigational Site, Kelantan, Malaysia|1288.18.60002 Boehringer Ingelheim Investigational Site, Melaka, Malaysia|1288.18.60005 Boehringer Ingelheim Investigational Site, Negeri Sembilan, Malaysia|1288.18.60007 Boehringer Ingelheim Investigational Site, Negeri Sembilan, Malaysia|1288.18.60001 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1288.18.60006 Boehringer Ingelheim Investigational Site, Perak, Malaysia|1288.18.60008 Boehringer Ingelheim Investigational Site, Putrajaya, Malaysia|1288.18.60003 Boehringer Ingelheim Investigational Site, Selangor, Malaysia|1288.18.63003 Boehringer Ingelheim Investigational Site, Cebu City, Philippines|1288.18.63007 Boehringer Ingelheim Investigational Site, Cebu, Philippines|1288.18.63002 Boehringer Ingelheim Investigational Site, Makati City, Philippines|1288.18.63001 Boehringer Ingelheim Investigational Site, Manila, Philippines|1288.18.63008 Boehringer Ingelheim Investigational Site, Quezon City, Philippines|1288.18.63006 Boehringer Ingelheim Investigational Site, Surigao, Philippines|1288.18.63005 Boehringer Ingelheim Investigational Site, Tagum City, Philippines|1288.18.84003 Boehringer Ingelheim Investigational Site, Hanoi, Vietnam|1288.18.84001 Boehringer Ingelheim Investigational Site, Ho Chi Minh City, Vietnam|1288.18.84002 Boehringer Ingelheim Investigational Site, Ho Chi Minh City, Vietnam
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