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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Byetta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse event incidence.
Time Frame: 3 years
Number of Adverse Drug Reactions
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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