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

July 17, 2020 updated by: AstraZeneca
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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

2948

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, D5550C00001
        • Research Site
      • Akita, Japan, D5550C00001
        • Research Site
      • Aomori, Japan, D5550C00001
        • Research Site
      • Chiba, Japan, D5550C00001
        • Research Site
      • Ehime, Japan, D5550C00001
        • Research Site
      • Fukuoka, Japan, D5550C00001
        • Research Site
      • Fukushima, Japan, D5550C00001
        • Research Site
      • Gifu, Japan, D5550C00001
        • Research Site
      • Gunma, Japan, D5550C00001
        • Research Site
      • Hiroshima, Japan, D5550C00001
        • Research Site
      • Hokkaido, Japan, D5550C00001
        • Research Site
      • Hyogo, Japan, D5550C00001
        • Research Site
      • Ibaraki, Japan, D5550C00001
        • Research Site
      • Ishikawa, Japan, D5550C00001
        • Research Site
      • Iwate, Japan, D5550C00001
        • Research Site
      • Kagawa, Japan, D5550C00001
        • Research Site
      • Kagoshima, Japan, D5550C00001
        • Research Site
      • Kanagawa, Japan, D5550C00001
        • Research Site
      • Kochi, Japan, D5550C00001
        • Research Site
      • Kumamoto, Japan, D5550C00001
        • Research Site
      • Kyoto, Japan, D5550C00001
        • Research Site
      • Mie, Japan, D5550C00001
        • Research Site
      • Miyagi, Japan, D5550C00001
        • Research Site
      • Miyazaki, Japan, D5550C00001
        • Research Site
      • Nagano, Japan, D5550C00001
        • Research Site
      • Nagasaki, Japan, D5550C00001
        • Research Site
      • Nara, Japan, D5550C00001
        • Research Site
      • Niigata, Japan, D5550C00001
        • Research Site
      • Oita, Japan, D5550C00001
        • Research Site
      • Okayama, Japan, D5550C00001
        • Research Site
      • Okinawa, Japan, D5550C00001
        • Research Site
      • Osaka, Japan, D5550C00001
        • Research Site
      • Saga, Japan, D5550C00001
        • Research Site
      • Saitama, Japan, D5550C00001
        • Research Site
      • Shiga, Japan, D5550C00001
        • Research Site
      • Shimane, Japan, D5550C00001
        • Research Site
      • Shizuoka, Japan, D5550C00001
        • Research Site
      • Tochigi, Japan, D5550C00001
        • Research Site
      • Tokushima, Japan, D5550C00001
        • Research Site
      • Tokyo, Japan, D5550C00001
        • Research Site
      • Tottori, Japan, D5550C00001
        • Research Site
      • Toyama, Japan, D5550C00001
        • Research Site
      • Wakayama, Japan, D5550C00001
        • Research Site
      • Yamagata, Japan, D5550C00001
        • Research Site
      • Yamaguchi, Japan, D5550C00001
        • Research Site
      • Yamanashi, Japan, D5550C00001
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event incidence.
Time Frame: 3 years
Number of Adverse Drug Reactions
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of HbA1c.
Time Frame: 3 years
Change value of HbA1c from baseline as mean / median / minimum / max.
3 years
Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).
Time Frame: 3 years
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.
3 years
Mean change in weight.
Time Frame: 3 years
3 years
Mean change in blood pressure.
Time Frame: 3 years.
3 years.
Mean change in lipid metabolism.
Time Frame: 3 years
Change value of lipid metabolism from baseline as mean / median / minimum / max.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2011

Primary Completion (Actual)

October 3, 2019

Study Completion (Actual)

October 3, 2019

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D5550C00001
  • EUPAS19606 (Registry Identifier: ENCePP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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