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Clinical Trial Details

Trial ID: L3817
Source ID: NCT00654381
Associated Drug: Bi 1356
Title: Japanese P III vs Voglibose and Placebo
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00654381/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 1356|DRUG: BI 1356|DRUG: voglibose placebo|DRUG: BI 1356 placebo|DRUG: voglibose
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 12, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication, 12 weeks|Change From Baseline in HbA1c at Week 26, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication, 26 weeks|Examination of Long-term Safety of Linagliptin (52-week Treatment), The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks, 52 weeks | Secondary: Relative Efficacy Response of HbA1c at Week 12, HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12, 12 weeks|Relative Efficacy Response of HbA1c at Week 26, HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26, 26 weeks|Relative Efficacy Response of HbA1c at Week 52, HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52, 52 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication, 12 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication, 26 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52, Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication, 52 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 561
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-04
Completion Date:
Results First Posted: 2011-08-02
Last Update Posted: 2014-01-27
Locations: 1218.23.05 Boehringer Ingelheim Investigational Site, Asahi, Chiba, Japan|1218.23.06 Boehringer Ingelheim Investigational Site, Funabashi, Chiba, Japan|1218.23.21 Boehringer Ingelheim Investigational Site, Hitachinaka, Ibaraki, Japan|1218.23.44 Boehringer Ingelheim Investigational Site, Hitachiota, Ibaraki, Japan|1218.23.09 Boehringer Ingelheim Investigational Site, Imizu, Toyama, Japan|1218.23.45 Boehringer Ingelheim Investigational Site, Inashiki-gun, Ibaraki, Japan|1218.23.13 Boehringer Ingelheim Investigational Site, Izumisano, Osaka, Japan|1218.23.27 Boehringer Ingelheim Investigational Site, Kariya, Aichi, Japan|1218.23.47 Boehringer Ingelheim Investigational Site, Kitakatsushika-gun, Saitama, Japan|1218.23.39 Boehringer Ingelheim Investigational Site, Kitakyuushuu, Fukuoka, Japan|1218.23.02 Boehringer Ingelheim Investigational Site, Koriyama, Fukushima, Japan|1218.23.03 Boehringer Ingelheim Investigational Site, Koriyama, Fukushima, Japan|1218.23.10 Boehringer Ingelheim Investigational Site, Kyoto, Kyoto, Japan|1218.23.37 Boehringer Ingelheim Investigational Site, Marugame, Kagawa, Japan|1218.23.38 Boehringer Ingelheim Investigational Site, Marugame, Kagawa, Japan|1218.23.23 Boehringer Ingelheim Investigational Site, Matsumoto, Nagano, Japan|1218.23.07 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan|1218.23.25 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.23.26 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.23.28 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.23.29 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.23.30 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.23.04 Boehringer Ingelheim Investigational Site, Naka, Ibaraki, Japan|1218.23.15 Boehringer Ingelheim Investigational Site, Nishi-ku, Hiroshima, Hiroshima, Japan|1218.23.34 Boehringer Ingelheim Investigational Site, Nishi-ku, Sakai, Osaka, Japan|1218.23.22 Boehringer Ingelheim Investigational Site, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan|1218.23.16 Boehringer Ingelheim Investigational Site, Oita, Oita, Japan|1218.23.40 Boehringer Ingelheim Investigational Site, Oita, Oita, Japan|1218.23.36 Boehringer Ingelheim Investigational Site, Okayama, Okayama, Japan|1218.23.11 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.23.12 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.23.32 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.23.33 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.23.35 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan|1218.23.17 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.18 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.19 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.41 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.42 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.43 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.23.01 Boehringer Ingelheim Investigational Site, Sendai, Miyagi, Japan|1218.23.20 Boehringer Ingelheim Investigational Site, Sendai, Miyagi, Japan|1218.23.46 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1218.23.08 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan|1218.23.14 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1218.23.31 Boehringer Ingelheim Investigational Site, Takatsuki, Osaka, Japan|1218.23.48 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan
URL: https://clinicaltrials.gov/show/NCT00654381