Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01817569
First received: March 21, 2013
Last updated: July 18, 2016
Last verified: July 2016
  Purpose
The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices.

Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse event incidence. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of Adverse Drug Reactions


Secondary Outcome Measures:
  • Mean change of HbA1c. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Change value of HbA1c from baseline as mean / median / minimum / max.

  • Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment.

  • Mean change in weight. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mean change in blood pressure. [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
  • Mean change in lipid metabolism. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Change value of lipid metabolism from baseline as mean / median / minimum / max.


Estimated Enrollment: 3100
Study Start Date: February 2011
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Detailed Description:
Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are eligible to be included in the study if they meet all of the following criteria:

The patient who is diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

The patient follows the PI of Byetta.

Criteria

Inclusion Criteria:

- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.

  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: NCT01817569

Contacts
Contact: Maki Inoue M.Inoue@astrazeneca.com

  Hide Study Locations
Locations
Japan
Research Site Active, not recruiting
Aichi, Japan
Research Site Withdrawn
Aichi, Japan
Research Site Recruiting
Aichi, Japan
Research Site Completed
Akita, Japan
Research Site Withdrawn
Akita, Japan
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Akita, Japan
Research Site Recruiting
Akita, Japan
Research Site Recruiting
Aomori, Japan
Research Site Completed
Aomori, Japan
Research Site Withdrawn
Aomori, Japan
Research Site Withdrawn
Chiba, Japan
Research Site Completed
Chiba, Japan
Research Site Recruiting
Chiba, Japan
Research Site Active, not recruiting
Chiba, Japan
Research Site Active, not recruiting
Ehime, Japan
Research Site Recruiting
Ehime, Japan
Research Site Withdrawn
Ehime, Japan
Research Site Recruiting
Fukuoka, Japan
Research Site Withdrawn
Fukuoka, Japan
Research Site Completed
Fukuoka, Japan
Research Site Active, not recruiting
Fukuoka, Japan
Research Site Recruiting
Fukushima, Japan
Research Site Withdrawn
Fukushima, Japan
Research Site Active, not recruiting
Fukushima, Japan
Research Site Withdrawn
Gifu, Japan
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Gifu, Japan
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Gifu, Japan
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Gunma, Japan
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Gunma, Japan
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Gunma, Japan
Research Site Withdrawn
Gunma, Japan
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Hiroshima, Japan
Research Site Recruiting
Hiroshima, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hokkaido, Japan
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Hokkaido, Japan
Research Site Withdrawn
Hokkaido, Japan
Research Site Withdrawn
Hyogo, Japan
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Hyogo, Japan
Research Site Active, not recruiting
Hyogo, Japan
Research Site Terminated
Hyogo, Japan
Research Site Completed
Hyogo, Japan
Research Site Withdrawn
Ibaraki, Japan
Research Site Active, not recruiting
Ibaraki, Japan
Research Site Completed
Ibaraki, Japan
Research Site Recruiting
Ibaraki, Japan
Research Site Active, not recruiting
Ishikawa, Japan
Research Site Completed
Ishikawa, Japan
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Ishikawa, Japan
Research Site Recruiting
Ishikawa, Japan
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Iwate, Japan
Research Site Completed
Iwate, Japan
Research Site Withdrawn
Iwate, Japan
Research Site Recruiting
Kagawa, Japan
Research Site Withdrawn
Kagawa, Japan
Research Site Withdrawn
Kagoshima, Japan
Research Site Terminated
Kagoshima, Japan
Research Site Recruiting
Kagoshima, Japan
Research Site Terminated
Kanagawa, Japan
Research Site Recruiting
Kanagawa, Japan
Research Site Completed
Kanagawa, Japan
Research Site Withdrawn
Kanagawa, Japan
Research Site Active, not recruiting
Kanagawa, Japan
Research Site Withdrawn
Kochi, Japan
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Kochi, Japan
Research Site Withdrawn
Kumamoto, Japan
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Kumamoto, Japan
Research Site Active, not recruiting
Kumamoto, Japan
Research Site Completed
Kyoto, Japan
Research Site Withdrawn
Kyoto, Japan
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Kyoto, Japan
Research Site Not yet recruiting
Kyoto, Japan
Research Site Withdrawn
Mie, Japan
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Mie, Japan
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Mie, Japan
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Miyagi, Japan
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Miyagi, Japan
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Miyagi, Japan
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Miyagi, Japan
Research Site Completed
Miyazaki, Japan
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Miyazaki, Japan
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Miyazaki, Japan
Research Site Active, not recruiting
Miyazaki, Japan
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Nagano, Japan
Research Site Completed
Nagano, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagasaki, Japan
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Nagasaki, Japan
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Nara, Japan
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Nara, Japan
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Nara, Japan
Research Site Withdrawn
Niigata, Japan
Research Site Active, not recruiting
Niigata, Japan
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Niigata, Japan
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Niigata, Japan
Research Site Not yet recruiting
Oita, Japan
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Oita, Japan
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Oita, Japan
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Oita, Japan
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Oita, Japan
Research Site Withdrawn
Okayama, Japan
Research Site Completed
Okayama, Japan
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Okayama, Japan
Research Site Active, not recruiting
Okinawa, Japan
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Okinawa, Japan
Research Site Withdrawn
Okinawa, Japan
Research Site Withdrawn
Osaka, Japan
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Osaka, Japan
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Osaka, Japan
Research Site Active, not recruiting
Osaka, Japan
Research Site Completed
Saga, Japan
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Saga, Japan
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Saga, Japan
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Saitama, Japan
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Saitama, Japan
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Saitama, Japan
Research Site Completed
Saitama, Japan
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Shiga, Japan
Research Site Recruiting
Shimane, Japan
Research Site Withdrawn
Shimane, Japan
Research Site Active, not recruiting
Shizuoka, Japan
Research Site Recruiting
Shizuoka, Japan
Research Site Completed
Shizuoka, Japan
Research Site Withdrawn
Shizuoka, Japan
Research Site Recruiting
Tochigi, Japan
Research Site Completed
Tochigi, Japan
Research Site Withdrawn
Tochigi, Japan
Research Site Completed
Tokushima, Japan
Research Site Recruiting
Tokushima, Japan
Research Site Not yet recruiting
Tokyo, Japan
Research Site Active, not recruiting
Tokyo, Japan
Research Site Withdrawn
Tokyo, Japan
Research Site Recruiting
Tokyo, Japan
Research Site Completed
Tokyo, Japan
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Tottori, Japan
Research Site Completed
Tottori, Japan
Research Site Recruiting
Toyama, Japan
Research Site Withdrawn
Wakayama, Japan
Research Site Recruiting
Wakayama, Japan
Research Site Recruiting
Yamagata, Japan
Research Site Withdrawn
Yamagata, Japan
Research Site Active, not recruiting
Yamagata, Japan
Research Site Active, not recruiting
Yamaguchi, Japan
Research Site Completed
Yamaguchi, Japan
Research Site Recruiting
Yamaguchi, Japan
Research Site Withdrawn
Yamaguchi, Japan
Research Site Active, not recruiting
Yamanashi, Japan
Research Site Withdrawn
Yamanashi, Japan
Research Site Recruiting
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01817569     History of Changes
Other Study ID Numbers: D5550C00001 
Study First Received: March 21, 2013
Last Updated: July 18, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Diabetes Mellitus (DM)
Byetta
Exenatide

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 26, 2016