Type 2 DiabetesNCT00419484
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes and Hypertension, run by Dokkyo Medical University at 1 site in Japan.
Trial summary
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Dyslipidemia
- What is being tested?
- pioglitazone
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2004to Jul 2008
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes HbA1c: more than 7% and less than 9%
Who cannot join
- insulin treatment
Trial locations and contacts
1 site in 1 country.
Japan1 site
Dokkyo Medical University, Koshigaya Hospital
Koshigaya, Saitama, 343-8555
About this study
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.
Read the detailed description
Primary composite endpoints:
Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)
Secondary endpoints:
urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout
- Conditions
- Type 2 Diabetes, Hypertension, Dyslipidemia, Diabetic Nephropathy
- Being tested
- pioglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startMar 2004
- Study completionJul 2008
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.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Dokkyo Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Yoshimasa Aso, MD, Principal investigator, Dokkyo Medical University, Koshigaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419484
- Sponsor's protocol ID
- 0309
- Status last verified
- Jan 2007
- First submitted
- 5 Jan 2007
- Last updated
- 8 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00419484
- Acronym / sponsor ID
- 0309
- Conditions
- Type 2 Diabetes, Hypertension, Dyslipidemia, Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Dokkyo Medical UniversityUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jul 2008
- First posted
- 8 Jan 2007 (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.
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.
Detailed description
Primary composite endpoints:
Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)
Secondary endpoints:
urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes HbA1c: more than 7% and less than 9%
Key exclusion criteria (1 listed)
- insulin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Jan 2007.
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.
Yoshimasa Aso, MD principal investigator
Dokkyo Medical University, Koshigaya Hospital
1 site 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 and Hypertension, run by Dokkyo Medical University at 1 site 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 1 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 8 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 8 Jan 2007.