Specific Clinical Experience Investigation for Long-term Use of Bydureon.
NCT ID: NCT01940770
Last Updated: 2020-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1137 participants
OBSERVATIONAL
2013-10-18
2019-11-29
Brief Summary
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Detailed Description
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1. Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
2. Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.
* Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
* Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
* Safety in patients with mild or moderate renal impairment
* Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
* Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
* Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
* Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
* Not the patient with severe renal impairment, including those receiving dialysis.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Shigeru Yoshida, MD
Role: STUDY_DIRECTOR
Quality & Safety Compliance Office
Locations
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Research Site
Aichi, , Japan
Research Site
Akita, , Japan
Research Site
Aomori, , Japan
Research Site
Chiba, , Japan
Research Site
Ehime, , Japan
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Fukui, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukushima, , Japan
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Gifu, , Japan
Research Site
Gunma, , Japan
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Hiroshima, , Japan
Research Site
Hokkaido, , Japan
Research Site
Hyōgo, , Japan
Research Site
Ibaraki, , Japan
Research Site
Ishikawa, , Japan
Research Site
Kagawa, , Japan
Research Site
Kagoshima, , Japan
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Kanagawa, , Japan
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Kochi, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
Research Site
Mie, , Japan
Research Site
Miyagi, , Japan
Research Site
Miyazaki, , Japan
Research Site
Nagano, , Japan
Research Site
Nagasaki, , Japan
Research Site
Nara, , Japan
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Niigata, , Japan
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Numakunai, , Japan
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Okayama, , Japan
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Okinawa, , Japan
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Osaka, , Japan
Research Site
Ōita, , Japan
Research Site
Saga, , Japan
Research Site
Saitama, , Japan
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Shiga, , Japan
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Shimane, , Japan
Research Site
Shizuoka, , Japan
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Tochigi, , Japan
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Tokushima, , Japan
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Tokyo, , Japan
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Tottori, , Japan
Research Site
Toyama, , Japan
Research Site
Wakayama, , Japan
Research Site
Yamagata, , Japan
Research Site
Yamaguchi, , Japan
Research Site
Yamanashi, , Japan
Countries
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Related Links
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Other Identifiers
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EUPAS18608
Identifier Type: REGISTRY
Identifier Source: secondary_id
D5551C00001
Identifier Type: -
Identifier Source: org_study_id
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