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

An observational study of Type 2 Diabetes, run by AstraZeneca at 46 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes
How many people: 2,948 participants
Where: 46 sitesJapan
Study dates: 13 Feb 2011to 3 Oct 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

46 sites in 1 country.

City, postcode or hospital

46 sites in 1 country

Japan46 sites

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

Other trials in Japan

About this study

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

Read the detailed description

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

Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus (DM), Byetta, Exenatide
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01817569
Study group	Role	What they receive
Byetta		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse event incidence.
Number of Adverse Drug Reactions
Measured: 3 years

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20113 Oct 2019

First posted25 Mar 2013 (estimated)
Study start13 Feb 2011
Primary completion3 Oct 2019
Study completion3 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,948 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01817569
Sponsor's protocol ID: D5550C00001
Other IDs: EUPAS19606
Status last verified: Jul 2020
First submitted: 21 Mar 2013
Last updated: 20 Jul 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
ClinicalTrials.gov ID: NCT01817569
Acronym / sponsor ID: D5550C00001
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus (DM), Byetta, Exenatide
Study type: Observational
Recruitment status: Completed
Enrolment: 2,948 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 13 Feb 2011 (actual)
Primary completion: 3 Oct 2019 (actual)
Study completion: 3 Oct 2019 (actual)
First posted: 25 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Byetta	–	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Adverse event incidence.
Time frame: 3 years
Number of Adverse Drug Reactions

5 secondary outcomes

Mean change of HbA1c.
Time frame: 3 years
Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).
Time frame: 3 years
Mean change in weight.
Time frame: 3 years
Mean change in blood pressure.
Time frame: 3 years.
Mean change in lipid metabolism.
Time frame: 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
CSR SynopsisLink provided by the sponsor.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shigeru Yoshida, MD study director

AstraZeneca

46 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by AstraZeneca at 46 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event incidence. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01817569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.