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Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01650259
First received: July 24, 2012
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 monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).

Condition Intervention
Diabetes Mellitus, Type 2
Drug: OAD
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 in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures:
  • The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ]

Enrollment: 4554
Study Start Date: July 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral antidiabetic drug (OAD) Drug: OAD
OAD except Trazenta tablets
Trazenta Drug: Trazenta
Linagliptin

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3300
Criteria

Inclusion criteria:

  • Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
  • Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)

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: NCT01650259

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Locations
Japan
Boehringer Ingelheim Investigational Site
Abiko,Chiba, Japan
Boehringer Ingelheim Investigational Site
Ageo,Saitama, Japan
Boehringer Ingelheim Investigational Site
Akashi,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Aki,Hiroshima, Japan
Boehringer Ingelheim Investigational Site
Akishima,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Akita,Akita, Japan
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Amagasaki,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Amami,Kagoshima, Japan
Boehringer Ingelheim Investigational Site
Anan,Tokushima, Japan
Boehringer Ingelheim Investigational Site
Annaka,Gunma, Japan
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Aomori,Aomori, Japan
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Arakawa,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Asago,Hyogo, Japan
Boehringer Ingelheim Investigational Site
Asahikawa,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Asaka,Saitama, Japan
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Asakura,Fukuoka, Japan
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Ashikaga,Tochigi, Japan
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Aso,Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Atami,Shizuoka, Japan
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Atsugi,Kanagawa, Japan
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Ayabe,Kyoto, Japan
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Bizen,Okayama, Japan
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Chiba,Chiba, Japan
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Chichibu,Saitama, Japan
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Chigasaki,Kanagawa, Japan
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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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Chuo,Tokyo, Japan
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Cyoshi,Chiba, Japan
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Cyuo,Tokyo, Japan
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Date,Fukushima, Japan
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Ebetsu,Hokkaido, Japan
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Echizen,Fukui, Japan
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Edogawa,Tokyo, Japan
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Fucyu,Tokyo, Japan
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Fuefuki,Yamanashi, Japan
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Fuji,Shizuoka, Japan
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Fujieda,Shizuoka, Japan
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Fujimino,Saitama, Japan
Boehringer Ingelheim Investigational Site
Fujisawa,Kanagawa, Japan
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Fukui,Fukui, Japan
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Fukuoka,Fukuoka, Japan
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Fukuyama,Hiroshima, Japan
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Funabashi,Chiba, Japan
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Gifu,Gifu, Japan
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Gobo,Wakayama, Japan
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Gosen,Niigata, Japan
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Gosyogawara,Aomori, Japan
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Gotenba,Shizuoka, Japan
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Gufu,Gifu, Japan
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Gujyo,Gifu, Japan
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Gyoda,Saitama, Japan
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Habikino,Osaka, Japan
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Hachioji,Tokyo, Japan
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Hakodate,Hokkaido, Japan
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Hakui,Ishikawa, 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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Hanishina,Nagano, Japan
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Hannan,Osaka, Japan
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Hashima,Gifu, Japan
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Hashimoto,Wakayama, Japan
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Higashiibaraki,Ibaraki, Japan
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Higashiosaka,Osaka, Japan
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Hiki,Saitama, Japan
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Himeji,Hyogo, Japan
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Hioki,Kagoshima, Japan
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Hirakata,Osaka, Japan
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Hiroshima,Hiroshima, Japan
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Hitachi,Ibaraki, Japan
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Hitachinaka,Ibaraki, Japan
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Hitoyoshi,Kumamoto, Japan
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Hokuto,Hokkaido, Japan
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Ibaraki,Osaka, 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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Ichinoseki,Iwate, Japan
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Iga,Mie, Japan
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Iizuka,Fukuoka, Japan
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Ikeda,Osaka, Japan
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Imari,Saga, Japan
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Inazawa,Aichi, Japan
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Inukami,Shiga, Japan
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Inuyama,Aichi, Japan
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Inzai,Chiba, Japan
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Isehara,Kanagawa, Japan
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Itabashi,Tokyo, Japan
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Itoigawa,Niigata, Japan
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Itoshima,Fukuoka, Japan
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Iwakuni,Yamaguchi, Japan
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Iwamizawa,Hokkaido, Japan
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Iwata,Shizuoka, Japan
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Iyo,Ehime, Japan
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Izumi,Osaka, Japan
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Izumisano,Osaka, Japan
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Jyoetsu,Niigata, Japan
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Kadoma,Osaka, Japan
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Kagamigahara,Gifu, Japan
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Kagoshima,Kagoshima, Japan
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Kai,Yamanashi, Japan
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Kaizu,Gifu, Japan
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Kaizuka,Osaka, Japan
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Kakegawa,Shizuoka, Japan
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Kakogawa,Hyogo, Japan
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Kamagaya,Chiba, Japan
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Kameda,Hokkaido, Japan
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Kami,Kochi, Japan
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Kamiamakusa,Kumamoto, Japan
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Kamikawa,Hokkaido, 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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Kasai,Hyogo, Japan
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Kasaoka,Okayama, Japan
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Kashihara,Nara, Japan
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Kashima,Ibaraki, Japan
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Kashiwa,Chiba, 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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Kato,Hyogo, Japan
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Katori,Chiba, Japan
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Katsushika,Tokyo, 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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Kesennuma,Miyagi, Japan
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Kinokawa,Wakayama, Japan
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Kirishima,Kagoshima, Japan
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Kiryu,Gunma, Japan
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Kishiwada,Osaka, Japan
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Kiso,Nagano, Japan
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Kita,Tokyo, Japan
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Kitaakita,Akita, Japan
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Kitagunma,Gunma, Japan
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Kitahiroshima,Hokkaido, Japan
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Kitakatsuragi,Nara, Japan
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Kitakyusyu,Fukuoka, Japan
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Kitami,Hokkaido, Japan
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Kitasaku,Nagano, Japan
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Kitashitara,Aichi, Japan
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Kiyose,Tokyo, Japan
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Kobayashi,Miyazaki, Japan
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Kobe,Hyogo, Japan
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Kochi,Kochi, Japan
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Kodama,Saitama, Japan
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Kofu,Yamanashi, Japan
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Kokubunji,Tokyo, Japan
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Komatsu,Ishikawa, Japan
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Konan,Aichi, Japan
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Konan,Shiga, Japan
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Konosu,Saitama, Japan
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Kooriyama,Fukushima, Japan
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Koshigaya,Saitama, Japan
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Koto,Tokyo, Japan
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Koutou,Tokyo, Japan
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Kumamoto,Kumamoto, Japan
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Kunitachi,Tokyo, Japan
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Kurashiki,Okayama, Japan
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Kure,Hiroshima, Japan
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Kurume,Fukuoka, Japan
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Kushiro,Hokkaido, Japan
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Kyoto,Kyoto, Japan
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Machida,Tokyo, Japan
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Maebashi,Gunma, Japan
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Maizuru,Kyoto, Japan
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Marugame,Kagawa, Japan
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Matsue,Shimane, Japan
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Matsuyama,Ehime, Japan
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Matsuzaka,Mie, Japan
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Meguro,Tokyo, Japan
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Mihara,Hiroshima, Japan
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Minamata,Kumamoto, Japan
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Minamikyusyu,Kagoshima, Japan
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Minamisaku,Nagano, Japan
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Minato,Tokyo, Japan
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Minokamo,Gifu, Japan
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Mishima,Shizuoka, Japan
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Mitaka,Tokyo, Japan
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Mito,Ibaraki, Japan
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Miyako,Iwate, Japan
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Miyakonojyo,Miyazaki, Japan
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Miyazaki,Miyazaki, Japan
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Moriguchi,Osaka, Japan
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Morioka,Iwate, Japan
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Moriyama,Shiga, Japan
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Motosu,Gifu, Japan
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Murayama,Yamagata, Japan
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Muroran,Hokkaido, Japan
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Myozai,Tokushima, Japan
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Nagano,Nagano, Japan
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Nagasaki,Nagasaki, Japan
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Nagoya,Aichi, Japan
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Naka,Ibaraki, Japan
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Nakagami,Okinawa, Japan
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Nakagawa,Hokkaido, Japan
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Nakatsu,Oita, Japan
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Nakatsugawa,Gifu, Japan
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Nara,Nara, Japan
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Natori,Miyagi, Japan
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Nayoro,Hokkaido, Japan
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Neyagawa,Osaka, Japan
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Niigata,Niigata, Japan
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Niihama,Ehime, Japan
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Nikko,Tochigi, Japan
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Ninohe,Iwate, Japan
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Nishinomiya,Hyogo, Japan
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Nishitokyo,Tokyo, Japan
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Nishiyatsushiro,Yamanashi, Japan
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Nobeoka,Miyazaki, Japan
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Noshiro,Akita, Japan
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Obu,Aichi, 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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Okaya,Nagano, 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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Omaezaki,Shizuoka, Japan
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Omihachiman,Shiga, Japan
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Omura,Nagasaki, Japan
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Omuta,Fukuoka, Japan
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Onga,Fukuoka, Japan
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Onojyou,Fukuoka, Japan
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Onomichi,Hiroshima, Japan
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Osaka,Osaka, Japan
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Osaki,Miyagi, Japan
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Ota,Gunma, Japan
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Ota,Tokyo, Japan
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Otaru,Hokkaido, Japan
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Otsu,Shiga, Japan
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Otsuki,Yamanashi, Japan
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Oume,Tokyo, Japan
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Owase,Mie, Japan
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Oyama,Tochigi, Japan
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Ritto,Shiga, Japan
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Ryugasaki,Ibaraki, Japan
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Saga,Saga, Japan
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Sagamihara,Kanagawa, Japan
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Saitama,Saitama, Japan
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Sakai,Osaka, Japan
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Sakurai,Nara, 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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Sasebo,Nagasaki, Japan
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Satsumasendai,Kagoshima, Japan
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Sendai,Miyagi, Japan
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Setagaya,Tokyo, Japan
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Shibata,Niigata, Japan
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Shima,Mie, Japan
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Shimabara,Nagasaki, Japan
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Shimada,Shizuoka, Japan
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Shimoina,Nagano, Japan
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Shimoniikawa,Toyama, Japan
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Shimonoseki,Yamaguchi, Japan
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Shimotsuga,Tochigi, Japan
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Shinagawa,Tokyo, Japan
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Shinjyuku,Tokyo, Japan
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Shiogama,Miyagi, Japan
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Shiwa,Iwate, Japan
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Shizuoka,Shizuoka, Japan
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Shobara,Hiroshima, Japan
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Sojya,Okayama, Japan
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Souka,Saitama, Japan
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Suginami,Tokyo, Japan
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Suita,Osaka, Japan
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Sumida,Tokyo, Japan
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Sunto,Shizuoka, Japan
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Susono,Shizuoka, Japan
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Suzaka,Nagano, Japan
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Suzuka,Mie, Japan
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Tachikawa,Tokyo, Japan
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Tagawa,Fukuoka, Japan
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Tahara,Aichi, Japan
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Taito,Tokyo, Japan
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Tajimi,Gifu, Japan
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Takamastu,Kagawa, Japan
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Takamatsu,Kagawa, Japan
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Takaoka,Toyama, Japan
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Takarazuka,Hyogo, Japan
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Takasaki,Gunma, Japan
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Takatsuki,Osaka, Japan
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Takehara,Hiroshima, Japan
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Tamana,Kumamoto, Japan
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Tanba,Hyogo, Japan
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Tatsuno,Hyogo, Japan
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Toba,Mie, Japan
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Toda,Saitama, Japan
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Tokamachi,Niigata, Japan
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Toki,Gifu, Japan
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Tokorozawa,Saitama, Japan
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Tokushima,Tokushima, Japan
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Tomioka,Gunma, Japan
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Tonami,Toyama, Japan
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Tondabayashi,Osaka, Japan
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Tone,Gunma, 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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Toyoake,Aichi, Japan
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Toyohashi,Aichi, Japan
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Toyokawa,Aichi, Japan
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Toyonaka,Osaka, Japan
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Toyooka,Hyogo, Japan
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Tsu,Mie, Japan
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Tsuchiura,Ibaraki, Japan
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Tsukuba,Ibaraki, Japan
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Tsukubo,Okayama, Japan
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Tsuruga,Fukui, Japan
Boehringer Ingelheim Investigational Site
Tsuruoka,Yamagata, Japan
Boehringer Ingelheim Investigational Site
Tsuyama,Okayama, Japan
Boehringer Ingelheim Investigational Site
Ube,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Uji,Kyoto, Japan
Boehringer Ingelheim Investigational Site
Ureshino,Saga, Japan
Boehringer Ingelheim Investigational Site
Uruma,Okinawa, Japan
Boehringer Ingelheim Investigational Site
Usuki,Oita, Japan
Boehringer Ingelheim Investigational Site
Utsunomiya,Tochigi, Japan
Boehringer Ingelheim Investigational Site
Uwajima,Ehime, Japan
Boehringer Ingelheim Investigational Site
Wakayama,Wakayama, Japan
Boehringer Ingelheim Investigational Site
Wako,Saitama, Japan
Boehringer Ingelheim Investigational Site
Watarai,Mie, Japan
Boehringer Ingelheim Investigational Site
Watari,Miyagi, Japan
Boehringer Ingelheim Investigational Site
Yaizu,Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Yama,Fukushima, Japan
Boehringer Ingelheim Investigational Site
Yamagata,Yamagata, Japan
Boehringer Ingelheim Investigational Site
Yamaguchi,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Yamato,Kanagawa, Japan
Boehringer Ingelheim Investigational Site
Yamatotakada,Nara, Japan
Boehringer Ingelheim Investigational Site
Yanagawa,Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Yanai,Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Yao,Osaka, 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
Yokote,Akita, Japan
Boehringer Ingelheim Investigational Site
Yonezawa,Yamagata, Japan
Boehringer Ingelheim Investigational Site
Yotsukaido,Chiba, Japan
Boehringer Ingelheim Investigational Site
Yurihonjyo,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: NCT01650259     History of Changes
Other Study ID Numbers: 1218.95
Study First Received: July 24, 2012
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 April 25, 2017