NCT01817569

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,948

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

46 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2019

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

8.6 years

First QC Date

March 21, 2013

Last Update Submit

July 17, 2020

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus (DM)ByettaExenatide

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence.

    Number of Adverse Drug Reactions

    3 years

Secondary Outcomes (5)

  • Mean change of HbA1c.

    3 years

  • Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).

    3 years

  • Mean change in weight.

    3 years

  • Mean change in blood pressure.

    3 years.

  • Mean change in lipid metabolism.

    3 years

Study Arms (1)

Byetta

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Research Site

Aichi, D5550C00001, Japan

Location

Research Site

Akita, D5550C00001, Japan

Location

Research Site

Aomori, D5550C00001, Japan

Location

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Chiba, D5550C00001, Japan

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Ehime, D5550C00001, Japan

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Research Site

Fukuoka, D5550C00001, Japan

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Fukushima, D5550C00001, Japan

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Gifu, D5550C00001, Japan

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Gunma, D5550C00001, Japan

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Hiroshima, D5550C00001, Japan

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Hokkaido, D5550C00001, Japan

Location

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Hyōgo, D5550C00001, Japan

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Ibaraki, D5550C00001, Japan

Location

Research Site

Ishikawa, D5550C00001, Japan

Location

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Kagawa, D5550C00001, Japan

Location

Research Site

Kagoshima, D5550C00001, Japan

Location

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Kanagawa, D5550C00001, Japan

Location

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Kochi, D5550C00001, Japan

Location

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Kumamoto, D5550C00001, Japan

Location

Research Site

Kyoto, D5550C00001, Japan

Location

Research Site

Mie, D5550C00001, Japan

Location

Research Site

Miyagi, D5550C00001, Japan

Location

Research Site

Miyazaki, D5550C00001, Japan

Location

Research Site

Nagano, D5550C00001, Japan

Location

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Nagasaki, D5550C00001, Japan

Location

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Nara, D5550C00001, Japan

Location

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Niigata, D5550C00001, Japan

Location

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Numakunai, D5550C00001, Japan

Location

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Okayama, D5550C00001, Japan

Location

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Okinawa, D5550C00001, Japan

Location

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Osaka, D5550C00001, Japan

Location

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Ōita, D5550C00001, Japan

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Saga, D5550C00001, Japan

Location

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Saitama, D5550C00001, Japan

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Shiga, D5550C00001, Japan

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Shimane, D5550C00001, Japan

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Shizuoka, D5550C00001, Japan

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Tochigi, D5550C00001, Japan

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Research Site

Tokushima, D5550C00001, Japan

Location

Research Site

Tokyo, D5550C00001, Japan

Location

Research Site

Tottori, D5550C00001, Japan

Location

Research Site

Toyama, D5550C00001, Japan

Location

Research Site

Wakayama, D5550C00001, Japan

Location

Research Site

Yamagata, D5550C00001, Japan

Location

Research Site

Yamaguchi, D5550C00001, Japan

Location

Research Site

Yamanashi, D5550C00001, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shigeru Yoshida, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 25, 2013

Study Start

February 13, 2011

Primary Completion

October 3, 2019

Study Completion

October 3, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations

JP(46)