Type 2 DiabetesNCT01940770
Specific Clinical Experience Investigation for Long-term Use of Bydureon.
An observational study of Type 2 Diabetes, run by AstraZeneca at 47 sites in Japan.
Trial summary
To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,137 participants
- Where
- 47 sitesJapan
- Study dates
- 18 Oct 2013to 29 Nov 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: The patients with type 2 diabetes mellitus who will be given Bydureon for the first time and who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.
Who may be able to join
- The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.
Who cannot join
- No past history of hypersensitivity to the components of Bydureon.
- Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
- Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
- Not the patient with severe renal impairment, including those receiving dialysis.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Research Site
Aichi, D5551C00001
Research Site
Akita, D5551C00001
Research Site
Aomori, D5551C00001
Research Site
Chiba, D5551C00001
Research Site
Ehime, D5551C00001
Research Site
Fukui, D5551C00001
Research Site
Fukuoka, D5551C00001
Research Site
Fukushima, D5551C00001
Research Site
Gifu, D5551C00001
Research Site
Gunma, D5551C00001
Research Site
Hiroshima, D5551C00001
Research Site
Hokkaido, D5551C00001
Research Site
Hyōgo, D5551C00001
Research Site
Ibaraki, D5551C00001
Research Site
Ishikawa, D5551C00001
Research Site
Kagawa, D5551C00001
Research Site
Kagoshima, D5551C00001
Research Site
Kanagawa, D5551C00001
Research Site
Kochi, D5551C00001
Research Site
Kumamoto, D5551C00001
Research Site
Kyoto, D5551C00001
Research Site
Mie, D5551C00001
Research Site
Miyagi, D5551C00001
Research Site
Miyazaki, D5551C00001
Research Site
Nagano, D5551C00001
Research Site
Nagasaki, D5551C00001
Research Site
Nara, D5551C00001
Research Site
Niigata, D5551C00001
Research Site
Numakunai, D5551C00001
Research Site
Ōita, D5551C00001
Research Site
Okayama, D5551C00001
Research Site
Okinawa, D5551C00001
Research Site
Osaka, D5551C00001
Research Site
Saga, D5551C00001
Research Site
Saitama, D5551C00001
Research Site
Shiga, D5551C00001
Research Site
Shimane, D5551C00001
Research Site
Shizuoka, D5551C00001
Research Site
Tochigi, D5551C00001
Research Site
Tokushima, D5551C00001
Research Site
Tokyo, D5551C00001
Research Site
Tottori, D5551C00001
Research Site
Toyama, D5551C00001
Research Site
Wakayama, D5551C00001
Research Site
Yamagata, D5551C00001
Research Site
Yamaguchi, D5551C00001
Research Site
Yamanashi, D5551C00001
About this study
Official title: Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
Read the detailed description
To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
- Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
- Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.
- Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
- Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
- Safety in patients with mild or moderate renal impairment
- Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
- Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
- Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus(DM), Bydureon, Exenatide
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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 (16)
Mean change of HbA1c
Change value of HbA1c from baseline as mean.
Measured: from baseline up to 3 years
Mean change of weight
Change value of weight from baseline as mean.
Measured: from baseline up to 3 years
Mean change of blood pressure
Change value of blood pressure from baseline as mean.
Measured: from baseline up to 3 years
Mean change of lipid metabolism
Change value of lipid metabolism from baseline as mean.
Measured: from baseline up to 3 years
Mean change of HbA1c
Change value of HbA1c from baseline as median.
Measured: from baseline up to 3 years
Mean change of HbA1c
Change value of HbA1c from baseline as minimum.
Measured: from baseline up to 3 years
Mean change of HbA1c
Change value of HbA1c from baseline as max.
Measured: from baseline up to 3 years
Mean change of weight
Change value of weight from baseline as median.
Measured: from baseline up to 3 years
Mean change of weight
Change value of weight from baseline as minimum.
Measured: from baseline up to 3 years
Mean change of weight
Change value of weight from baseline as max.
Measured: from baseline up to 3 years
Mean change of blood pressure
Change value of blood pressure from baseline as median.
Measured: from baseline up to 3 years
Mean change of blood pressure
Change value of blood pressure from baseline as minimum.
Measured: from baseline up to 3 years
Mean change of blood pressure
Change value of blood pressure from baseline as max.
Measured: from baseline up to 3 years
Mean change of lipid metabolism
Change value of lipid metabolism from baseline as median.
Measured: from baseline up to 3 years
Mean change of lipid metabolism
Change value of lipid metabolism from baseline as minimum.
Measured: from baseline up to 3 years
Mean change of lipid metabolism
Change value of lipid metabolism from baseline as max.
Measured: from baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study start18 Oct 2013
- Primary completion29 Nov 2019
- Study completion29 Nov 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
- 1,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Yoshida, MD, Study director, Quality & Safety Compliance Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940770
- Sponsor's protocol ID
- D5551C00001
- Other IDs
- EUPAS18608
- Status last verified
- Jul 2020
- First submitted
- 9 Sep 2013
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
- ClinicalTrials.gov ID
- NCT01940770
- Acronym / sponsor ID
- D5551C00001
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus(DM), Bydureon, Exenatide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,137 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 12 Sep 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.
To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
Detailed description
To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
- Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
- Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.
- Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
- Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
- Safety in patients with mild or moderate renal impairment
- Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
- Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
- Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with type 2 diabetes mellitus who will be given Bydureon for the first time and who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.
Key inclusion criteria (1 listed)
- The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.
Key exclusion criteria (4 listed)
- No past history of hypersensitivity to the components of Bydureon.
- Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
- Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
- Not the patient with severe renal impairment, including those receiving dialysis.
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
16 secondary outcomes
Mean change of HbA1c
Time frame: from baseline up to 3 years
Mean change of weight
Time frame: from baseline up to 3 years
Mean change of blood pressure
Time frame: from baseline up to 3 years
Mean change of lipid metabolism
Time frame: from baseline up to 3 years
Mean change of HbA1c
Time frame: from baseline up to 3 years
Mean change of HbA1c
Time frame: from baseline up to 3 years
Mean change of HbA1c
Time frame: from baseline up to 3 years
Mean change of weight
Time frame: from baseline up to 3 years
Mean change of weight
Time frame: from baseline up to 3 years
Mean change of weight
Time frame: from baseline up to 3 years
Mean change of blood pressure
Time frame: from baseline up to 3 years
Mean change of blood pressure
Time frame: from baseline up to 3 years
Mean change of blood pressure
Time frame: from baseline up to 3 years
Mean change of lipid metabolism
Time frame: from baseline up to 3 years
Mean change of lipid metabolism
Time frame: from baseline up to 3 years
Mean change of lipid metabolism
Time frame: from baseline up to 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.
- Individual participant dataSharing planned: No
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
Quality & Safety Compliance Office
47 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 47 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 4 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 47 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?
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.