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Clinical Trial Details

Trial ID: L1863
Source ID: NCT01204294
Associated Drug: Linagliptin
Title: Comprehensive Add on Study in Japan
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01204294/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Linagliptin|DRUG: Linagliptin|DRUG: Metformin|DRUG: Metformin|DRUG: Linagliptin|DRUG: Linagliptin|DRUG: Linagliptin
Outcome Measures: Primary: Incidence of Adverse Events (AEs), The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events, The first drug administration through 7 days after the last drug administration, up to 382 days | Secondary: Glycosylated Haemoglobin A1c (HbA1c), The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value., Baseline and 52 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 574
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-09
Completion Date: 2012-01
Results First Posted: 2013-01-23
Last Update Posted: 2014-03-28
Locations: 1218.78.008 Boehringer Ingelheim Investigational Site, Akishima, Tokyo, Japan|1218.78.030 Boehringer Ingelheim Investigational Site, Amagasaki, Hyogo, Japan|1218.78.017 Boehringer Ingelheim Investigational Site, Annaka, Gunma, Japan|1218.78.006 Boehringer Ingelheim Investigational Site, Aomori, Aomori, Japan|1218.78.007 Boehringer Ingelheim Investigational Site, Aomori, Aomori, Japan|1218.78.009 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1218.78.013 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1218.78.032 Boehringer Ingelheim Investigational Site, Fukuoka, Fukuoka, Japan|1218.78.040 Boehringer Ingelheim Investigational Site, Fukuoka, Fukuoka, Japan|1218.78.037 Boehringer Ingelheim Investigational Site, Higashi Osaka, Osaka, Japan|1218.78.043 Boehringer Ingelheim Investigational Site, Hitachinaka, Ibaraki, Japan|1218.78.019 Boehringer Ingelheim Investigational Site, Isesaki, Gunma, Japan|1218.78.036 Boehringer Ingelheim Investigational Site, Kashiwara, Osaka, Japan|1218.78.026 Boehringer Ingelheim Investigational Site, Kasugai, Aichi, Japan|1218.78.038 Boehringer Ingelheim Investigational Site, Kawachinagano, Osaka, Japan|1218.78.021 Boehringer Ingelheim Investigational Site, Kitaazumi-gun, Nagano, Japan|1218.78.022 Boehringer Ingelheim Investigational Site, Matsumoto, Nagano, Japan|1218.78.033 Boehringer Ingelheim Investigational Site, Matsumoto, Nagano, Japan|1218.78.012 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan|1218.78.041 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan|1218.78.034 Boehringer Ingelheim Investigational Site, Morioka, Iwate, Japan|1218.78.035 Boehringer Ingelheim Investigational Site, Morioka, Iwate, Japan|1218.78.018 Boehringer Ingelheim Investigational Site, Moriya, Ibaraki, Japan|1218.78.024 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.78.025 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.78.027 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.78.028 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.78.031 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1218.78.039 Boehringer Ingelheim Investigational Site, Oita, Oita, Japan|1218.78.004 Boehringer Ingelheim Investigational Site, Okinawa, Okinawa, Japan|1218.78.016 Boehringer Ingelheim Investigational Site, Sagae, Yamagata, Japan|1218.78.001 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.78.020 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.78.042 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1218.78.005 Boehringer Ingelheim Investigational Site, Shimajiri-gun, Okinawa, Japan|1218.78.014 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1218.78.002 Boehringer Ingelheim Investigational Site, Shinjyuku-ku. Tokyo, Japan|1218.78.011 Boehringer Ingelheim Investigational Site, Shizuoka, Shizuoka, Japan|1218.78.003 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1218.78.023 Boehringer Ingelheim Investigational Site, Tokorozawa, Saitama, Japan|1218.78.029 Boehringer Ingelheim Investigational Site, Tokorozawa, Saitama, Japan|1218.78.010 Boehringer Ingelheim Investigational Site, Tsuchiura, Ibaraki, Japan|1218.78.015 Boehringer Ingelheim Investigational Site, Yamagata, Yamagata, Japan
URL: https://clinicaltrials.gov/show/NCT01204294

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details