Coronary Heart DiseaseEIIGETPCHDNCT00724542
Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
A study testing Voglibose tablets in people with Coronary Heart Disease and Impaired Glucose Tolerance, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Impaired Glucose Tolerance
- What is being tested?
- Voglibose tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Dec 2010
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary heart disease
- Impaired Glucose Tolerance
Who cannot join
- Age < 40yr or > 75yr
- Diabetes Mellitus
- Scr > 2.0 mg/dL（176 μmol/L）
- ALT or AST > 2.5 ULN
- Hb < 90g/L
- Heart Failure
- Infection
- Undergo other interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Libin Shi contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Wenhui Ding, Professor, 86-10-66551122 ext. 5001, dwh_rd@126.com
About this study
Official title: Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.
- Conditions
- Coronary Heart Disease, Impaired Glucose Tolerance
- Being tested
- Voglibose tablets
- Medical subject headings
- Coronary Disease, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voglibose tabletsDrug
0.2mg Tid
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Placebo with lifestyle intervention |
| Drug | Experimental | Voglibose tablets with lifestyle intervention Receives: Drug: Voglibose tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
TypeⅡDiabetes Mellitus
Measured: 2 years
Secondary outcomes (1)
Occurrence of Cardiovascular Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- Takeda
- Investigators
- Wenhui Ding, Professor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724542
- Sponsor's protocol ID
- 2006BAI01A02-11
- Acronym
- EIIGETPCHD
- Status last verified
- Aug 2008
- First submitted
- 25 Jul 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
- ClinicalTrials.gov ID
- NCT00724542
- Acronym / sponsor ID
- EIIGETPCHD / 2006BAI01A02-11
- Conditions
- Coronary Heart Disease, Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- Takeda
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 29 Jul 2008 (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 study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Placebo with lifestyle intervention |
| Drug | Experimental | Drug: Voglibose tabletsVoglibose tablets with lifestyle intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with coronary heart disease
- Impaired Glucose Tolerance
Key exclusion criteria (8 listed)
- Age < 40yr or > 75yr
- Diabetes Mellitus
- Scr > 2.0 mg/dL（176 μmol/L）
- ALT or AST > 2.5 ULN
- Hb < 90g/L
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 |
|---|---|---|
| Voglibose tablets0.2mg Tid | Drug | Drug |
Primary outcome
TypeⅡDiabetes Mellitus
Time frame: 2 years
1 secondary outcome
Occurrence of Cardiovascular Events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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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.
Libin Shi contact
Wenhui Ding, Professor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voglibose tablets in people with Coronary Heart Disease and Impaired Glucose Tolerance, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2008. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhui Ding, Professor (86-10-66551122 ext. 5001, dwh_rd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TypeⅡDiabetes Mellitus (time frame: 2 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 25 Aug 2008.