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PMS of Trazenta on the Long-term Use as Add-on Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01904383
First received: July 8, 2013
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Condition Intervention
Diabetes Mellitus, Type 2 Drug: Trazenta

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint to assess safety of Trazenta Tablets is the number (%) of patients with drug related adverse events [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures:
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ]
  • The change between baseline and observation period in Haemoglobin A1c (HbA1c) [ Time Frame: up to 156 weeks ]

Enrollment: 3640
Study Start Date: July 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Trazenta Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3000 patients with type 2 Diabetes Mellitus
Criteria

Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904383

  Hide Study Locations
Locations
Japan
Boehringer Ingelheim Investigational Site
Adachi,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Agatsuma,Gumma, Japan
Boehringer Ingelheim Investigational Site
Ageo,Saitama, Japan
Boehringer Ingelheim Investigational Site
Aisai,Aichi, Japan
Boehringer Ingelheim Investigational Site
Aki,Hiroshima, Japan
Boehringer Ingelheim Investigational Site
Akishima,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Akita,Akita, Japan
Boehringer Ingelheim Investigational Site
Amagasaki,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Amakusa,Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Anjo,Aichi, Japan
Boehringer Ingelheim Investigational Site
Aomori,Aomori, Japan
Boehringer Ingelheim Investigational Site
Arao,Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Arida,Wakayama, Japan
Boehringer Ingelheim Investigational Site
Asago,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Asahi,Chiba, Japan
Boehringer Ingelheim Investigational Site
Asahikawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Asakura,Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Atami,Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Atsugi,Kanagawa, Japan
Boehringer Ingelheim Investigational Site
Bibai,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Bizen,Okayama, Japan
Boehringer Ingelheim Investigational Site
Bungotakada,Oita, Japan
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Bunkyo,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Buzen,Fukuoka, Japan
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Chiba,Chiba, Japan
Boehringer Ingelheim Investigational Site
Chikugo,Fukuoka, Japan
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Chikushino,Fukuoka, Japan
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Chita,Aichi, Japan
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Chiyoda,Tokyo, Japan
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Chofu,Tokyo, Japan
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Chuo,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Daisen,Akita, Japan
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Daito,Osaka, Japan
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Date,Fukushima, Japan
Boehringer Ingelheim Investigational Site
Ebina,Kanagawa, Japan
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Echizen,Fukui, Japan
Boehringer Ingelheim Investigational Site
Edogawa,Tokyo, Japan
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Fuji,Shizuoka, Japan
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Fujinomiya,Shizuoka, Japan
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Fujisawa,Kanagawa, Japan
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Fukaya,Saitama, Japan
Boehringer Ingelheim Investigational Site
Fukui,Fukui, Japan
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Fukuoka,Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Fukuroi,Shizuoka, Japan
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Fukushima,Fukushima, Japan
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Fukuyama,Hiroshima, Japan
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Funabashi,Chiba, Japan
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Fussa,Tokyo, Japan
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Fuwa,Gifu, Japan
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Gamagori,Aichi, Japan
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Gamo,Shiga, Japan
Boehringer Ingelheim Investigational Site
Gifu,Gifu, Japan
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Gojo,Nara, Japan
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Goshogawara,Aomori, Japan
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Goto,Nagasaki, Japan
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Hachioji,Tokyo, Japan
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Haga,Tochigi, Japan
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Hakodate,Hokkaido, Japan
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Hakusan,Ishikawa, Japan
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Hamamatsu,Shizuoka, Japan
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Hanamaki,Iwate, Japan
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Handa,Aichi, Japan
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Hannan,Osaka, Japan
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Hanno,Saitama, Japan
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Hanyu,Saitama, Japan
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Hashima,Gifu, Japan
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Hasuda,Saitama, Japan
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Hatsukaichi,Hiroshima, Japan
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Hekinan,Aichi, Japan
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Hidaka,Hokkaido, Japan
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Higashihiroshima,Hiroshima, Japan
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Higashiibaraki,Ibaraki, Japan
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Higashikagawa,Kagawa, Japan
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Higashikurume,Tokyo, Japan
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Higashimorokata,Miyazaki, Japan
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Higashimurayama,Tokyo, Japan
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Higashiosaka,Osaka, Japan
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Higashiusuki,Miyazaki, Japan
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Hiki,Saitama, Japan
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Hikone,Shiga, Japan
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Himeji,Hyogo, Japan
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Hirado,Nagasaki, Japan
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Hirakata,Osaka, Japan
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Hiratsuka,Kanagawa, Japan
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Hirosaki,Aomori, Japan
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Hiroshima,Hiroshima, Japan
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Hitachi,Ibaraki, Japan
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Honjo,Saitama, Japan
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Hosu,Ishikawa, Japan
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Ibaraki,Osaka, Japan
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Ibi,Gifu, Japan
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Ibusuki,Kagoshima, Japan
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Ichihara,Chiba, Japan
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Ichikawa,Chiba, Japan
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Ichinomiya,Aichi, Japan
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Iizuka,Fukuoka, Japan
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Imizu,Toyama, Japan
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Inashiki,Ibaraki, Japan
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Inazawa,Aichi, Japan
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Inzai,Chiba, Japan
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Iruma,Saitama, Japan
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Isahaya,Nagasaki, Japan
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Ise,Mie, Japan
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Isesaki,Gumma, Japan
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Ishioka,Ibaraki, Japan
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Isumi,Chiba, Japan
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Itoshima,Fukuoka, Japan
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Iwaki,Fukushima, Japan
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Iwakuni,Yamaguchi, Japan
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Iwami,Tottori, Japan
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Iwamizawa,Hokkaido, Japan
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Izu,Shizuoka, Japan
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Izumi,Kagoshima, Japan
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Izumiotsu,Osaka, Japan
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Izumisano,Osaka, Japan
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Izumo,Shimane, Japan
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Joso,Ibaraki, Japan
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Kagoshima,Kagoshima, Japan
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Kai,Yamanashi, Japan
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Kamakura,Kanagawa, Japan
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Kameyama,Mie, Japan
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Kamikawa,Hokkaido, Japan
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Kamikita,Aomori, Japan
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Kamisu,Ibaraki, Japan
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Kamo,Shizuoka, Japan
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Kanazawa,Ishikawa, Japan
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Kanonji,Kagawa, Japan
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Kanoya,Kagoshima, Japan
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Karatsu,Saga, Japan
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Kariya,Aichi, Japan
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Kashima,Saga, Japan
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Kashiwa,Chiba, Japan
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Kashiwara,Osaka, Japan
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Kashiwazaki,Niigata, Japan
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Kasuga,Fukuoka, Japan
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Kasugai,Aichi, Japan
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Kasukabe,Saitama, Japan
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Kato,Hokkaido, Japan
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Kawachinagano,Osaka, Japan
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Kawagoe,Saitama, Japan
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Kawaguchi,Saitama, Japan
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Kawanishi,Hyogo, Japan
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Kawasaki,Kanagawa, Japan
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Kikuchi,Kumamoto, Japan
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Kin,Okinawa, Japan
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Kita,Ehime, Japan
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Kitakami,Iwate, Japan
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Kitakatsuragi,Nara, Japan
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Kitakyushu,Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Kitami,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Kitamoto,Saitama, Japan
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Kitanagoya,Aichi, Japan
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Kobe,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Kochi,Kochi, Japan
Boehringer Ingelheim Investigational Site
Kodaira,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Kofu,Yamanashi, Japan
Boehringer Ingelheim Investigational Site
Koga,Ibaraki, Japan
Boehringer Ingelheim Investigational Site
Kokubunji,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Komaki,Aichi, Japan
Boehringer Ingelheim Investigational Site
Komatsushima,Tokushima, Japan
Boehringer Ingelheim Investigational Site
Konan,Shiga, Japan
Boehringer Ingelheim Investigational Site
Koriyama,Fukushima, Japan
Boehringer Ingelheim Investigational Site
Kosai,Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Koshigaya,Saitama, Japan
Boehringer Ingelheim Investigational Site
Koshu,Yamanashi, Japan
Boehringer Ingelheim Investigational Site
Koyu,Miyazaki, Japan
Boehringer Ingelheim Investigational Site
Kuki,Saitama, Japan
Boehringer Ingelheim Investigational Site
Kuma,Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Kumagaya,Saitama, Japan
Boehringer Ingelheim Investigational Site
Kumamoto,Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Kunisaki,Oita, Japan
Boehringer Ingelheim Investigational Site
Kurashiki,Okayama, Japan
Boehringer Ingelheim Investigational Site
Kure,Hiroshima, Japan
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Kurume,Fukuoka, Japan
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Kusatsu,Shiga, Japan
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Kushiro,Hokkaido, Japan
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Kuwana,Mie, Japan
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Kyotanabe,Kyoto, Japan
Boehringer Ingelheim Investigational Site
Kyoto,Kyoto, Japan
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Machida,Tokyo, Japan
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Maebashi,Gumma, Japan
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Maizuru,Kyoto, Japan
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Maniwa,Okayama, Japan
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Marugame,Kagawa, Japan
Boehringer Ingelheim Investigational Site
Masuda,Shimane, Japan
Boehringer Ingelheim Investigational Site
Matsudo,Chiba, Japan
Boehringer Ingelheim Investigational Site
Matsumoto,Nagano, Japan
Boehringer Ingelheim Investigational Site
Matsusaka,Mie, Japan
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Matsuyama,Ehime, Japan
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Meguro,Tokyo, Japan
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Mihara,Hiroshima, Japan
Boehringer Ingelheim Investigational Site
Mikatakaminaka,Fukui, Japan
Boehringer Ingelheim Investigational Site
Minamikyushu,Kagoshima, Japan
Boehringer Ingelheim Investigational Site
Minato,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Minokamo,Gifu, Japan
Boehringer Ingelheim Investigational Site
Mito,Ibaraki, Japan
Boehringer Ingelheim Investigational Site
Miyaki,Saga, Japan
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Miyazaki,Miyazaki, Japan
Boehringer Ingelheim Investigational Site
Mizunami,Gifu, Japan
Boehringer Ingelheim Investigational Site
Mobara,Chiba, Japan
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Moriguchi,Osaka, Japan
Boehringer Ingelheim Investigational Site
Morioka,Iwate, Japan
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Muroran,Hokkaido, Japan
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Musashino,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Nabari,Mie, Japan
Boehringer Ingelheim Investigational Site
Nagai,Yamagata, Japan
Boehringer Ingelheim Investigational Site
Nagano,Nagano, Japan
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Nagaoka,Niigata, Japan
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Nagaokakyo,Kyoto, Japan
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Nagasaki,Nagasaki, Japan
Boehringer Ingelheim Investigational Site
Nagoya,Aichi, Japan
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Nakama,Fukuoka, Japan
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Nakano,Tokyo, Japan
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Nankoku,Kochi, Japan
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Nara,Nara, Japan
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Narashino,Chiba, Japan
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Nasushiobara,Tochigi, Japan
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Natori,Miyagi, Japan
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Nerima,Tokyo, Japan
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Neyagawa,Osaka, Japan
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Nichinan,Miyazaki, Japan
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Niigata,Niigata, Japan
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Niiza,Saitama, Japan
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Nishinomiya,Hyogo, Japan
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Nishishirakawa,Fukushima, Japan
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Nishiyatsushiro,Yamanashi, Japan
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Niwa,Aichi, Japan
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Numazu,Shizuoka, Japan
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Obihiro,Hokkaido, Japan
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Obu,Aichi, Japan
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Odate,Akita, Japan
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Odawara,Kanagawa, Japan
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Ogaki,Gifu, Japan
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Oita,Oita, Japan
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Okayama,Okayama, Japan
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Okazaki,Aichi, Japan
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Okegawa,Saitama, Japan
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Okinawa,Okinawa, Japan
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Omura,Nagasaki, Japan
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Omuta,Fukuoka, Japan
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Onuma,Fukushima, Japan
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Osaka,Osaka, Japan
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Osakasayama,Osaka, Japan
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Osaki,Miyagi, Japan
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Ota,Gumma, Japan
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Ota,Tokyo, Japan
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Otsu,Shiga, Japan
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Owariasahi,Aichi, Japan
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Oyama,Tochigi, Japan
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Ozu,Ehime, Japan
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Ritto,Shiga, Japan
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Sado,Niigata, Japan
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Saga,Saga, Japan
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Sagamihara,Kanagawa, Japan
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Saijo,Ehime, Japan
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Saiki,Oita, Japan
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Saitama,Saitama, Japan
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Sakai,Osaka, Japan
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Sakata,Yamagata, Japan
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Sakura,Chiba, Japan
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Sakura,Tochigi, Japan
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Sanjo,Niigata, Japan
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Sannohe,Aomori, Japan
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Sapporo,Hokkaido, Japan
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Sasayama,Hyogo, Japan
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Sayama,Saitama, Japan
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Semboku,Akita, Japan
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Sendai,Miyagi, Japan
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Setagaya,Tokyo, Japan
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Seto,Aichi, Japan
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Shibata,Niigata, Japan
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Shibuya,Tokyo, Japan
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Shimabara,Nagasaki, Japan
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Shimonoseki,Yamaguchi, Japan
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Shimotsuga,Tochigi, Japan
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Shimotsuke,Tochigi, Japan
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Shimotsuma,Ibaraki, Japan
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Shinagawa,Tokyo, Japan
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Shinjuku,Tokyo, Japan
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Shiwa,Iwate, Japan
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Shizuoka,Shizuoka, Japan
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Shunan,Yamaguchi, Japan
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So,Kagoshima, Japan
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Suita,Osaka, Japan
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Sukumo,Kochi, Japan
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Sumida,Tokyo, Japan
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Sumoto,Hyogo, Japan
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Sunto,Shizuoka, Japan
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Suzu,Ishikawa, Japan
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Tachikawa,Tokyo, Japan
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Tagawa,Fukuoka, Japan
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Taito,Tokyo, Japan
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Takamatsu,Kagawa, Japan
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Takarazuka,Hyogo, Japan
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Takasaki,Gumma, Japan
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Takatsuki,Osaka, Japan
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Tama,Tokyo, Japan
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Tamana,Kumamoto, Japan
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Tateyama,Chiba, Japan
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Tendo,Yamagata, Japan
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Tochigi,Tochigi, Japan
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Toda,Saitama, Japan
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Tokorozawa,Saitama, Japan
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Tokushima,Tokushima, Japan
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Tomigusuku,Okinawa, Japan
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Toon,Ehime, Japan
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Toride,Ibaraki, Japan
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Toshima,Tokyo, Japan
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Tosu,Saga, Japan
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Tottori,Tottori, Japan
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Towada,Aomori, Japan
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Toyama,Toyama, Japan
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Toyohashi,Aichi, Japan
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Toyonaka,Osaka, Japan
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Toyono,Osaka, Japan
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Toyota,Aichi, Japan
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Tsu,Mie, Japan
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Tsubame,Niigata, Japan
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Tsukuba,Ibaraki, Japan
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Tsukumi,Oita, Japan
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Tsuruoka,Yamagata, Japan
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Tsushima,Aichi, Japan
Boehringer Ingelheim Investigational Site
Ube,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Uda,Nara, Japan
Boehringer Ingelheim Investigational Site
Ueda,Nagano, Japan
Boehringer Ingelheim Investigational Site
Uji,Kyoto, Japan
Boehringer Ingelheim Investigational Site
Unnan,Shimane, Japan
Boehringer Ingelheim Investigational Site
Ureshino,Saga, Japan
Boehringer Ingelheim Investigational Site
Uruma,Okinawa, Japan
Boehringer Ingelheim Investigational Site
Wakayama,Wakayama, Japan
Boehringer Ingelheim Investigational Site
Yaita,Tochigi, Japan
Boehringer Ingelheim Investigational Site
Yaizu,Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Yamagata,Yamagata, Japan
Boehringer Ingelheim Investigational Site
Yamanashi,Yamanashi, Japan
Boehringer Ingelheim Investigational Site
Yanai,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Yao,Osaka, Japan
Boehringer Ingelheim Investigational Site
Yawatahama,Ehime, Japan
Boehringer Ingelheim Investigational Site
Yokkaichi,Mie, Japan
Boehringer Ingelheim Investigational Site
Yokohama,Kanagawa, Japan
Boehringer Ingelheim Investigational Site
Yokosuka,Kanagawa, Japan
Boehringer Ingelheim Investigational Site
Yonago,Tottori, Japan
Boehringer Ingelheim Investigational Site
Yoshida,Fukui, Japan
Boehringer Ingelheim Investigational Site
Yoshinogawa,Tokushima, Japan
Boehringer Ingelheim Investigational Site
Yubari,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Yufu,Oita, Japan
Boehringer Ingelheim Investigational Site
Yuki,Ibaraki, Japan
Boehringer Ingelheim Investigational Site
Yurihonjo,Akita, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01904383     History of Changes
Other Study ID Numbers: 1218.147
Study First Received: July 8, 2013
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 22, 2017