Type 2 Diabetes MellitusPhase 4PIOcardNCT00479986
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
A Phase 4 study testing pioglitazone in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by IKFE Institute for Clinical Research and Development at 2 sites in Germany.
Trial summary
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2005to Nov 2006
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- stable oral treatment with metfromin and/or sulfonylurea
- age 20 - 80 years
- angiographically confirmed atherosclerosis or hsCRP > 1 mg/l
Who cannot join
- type 1 diabetes
- HbA1c > 8.5 %
- severe disease
- acute coronary syndrome
- contraindications to pioglitazone (heart failure etc.)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.
Read the detailed description
PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- Being tested
- pioglitazone, placebo
- Keywords
- diabetes mellitus, monocyte activation, cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Not described Receives: Drug: pioglitazone |
| placebo | Active comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
Measured: 4 weeks
Secondary outcomes (2)
Safety
Measured: 4 weeks
Metabolic control (HbA1c, Glucose)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startJun 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- IKFE Institute for Clinical Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Johannes Gutenberg University Mainz, Heidelberg University
- Investigators
- Thomas Forst, MD, Principal investigator, IKFE - Institute for Clinical Research and Development, MainzAndreas Pfützner, MD, PhD, Study director, IKFE - Institute for Clinical Research and Development, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479986
- Sponsor's protocol ID
- ATS-K-016
- Acronym
- PIOcard
- Status last verified
- May 2007
- First submitted
- 29 May 2007
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00479986
- Acronym / sponsor ID
- PIOcard / ATS-K-016
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- Keywords
- diabetes mellitus, monocyte activation, cardiovascular risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- IKFE Institute for Clinical Research and DevelopmentUniversity, hospital or other
- Collaborators
- Takeda, Johannes Gutenberg University Mainz, Heidelberg University
- Study start
- Jun 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 30 May 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.
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.
Detailed description
PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: pioglitazone |
| placebo | Active comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes mellitus
- stable oral treatment with metfromin and/or sulfonylurea
- age 20 - 80 years
- angiographically confirmed atherosclerosis or hsCRP > 1 mg/l
Key exclusion criteria (5 listed)
- type 1 diabetes
- HbA1c > 8.5 %
- severe disease
- acute coronary syndrome
- contraindications to pioglitazone (heart failure etc.)
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 | Pioglitazone |
| placebo | Drug | placebo |
Primary outcome
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
Time frame: 4 weeks
2 secondary outcomes
Safety
Time frame: 4 weeks
Metabolic control (HbA1c, Glucose)
Time frame: 4 weeks
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 1 Apr 2015.
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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.
Thomas Forst, MD principal investigator
IKFE - Institute for Clinical Research and Development, Mainz
Andreas Pfützner, MD, PhD study director
IKFE - Institute for Clinical Research and Development, Mainz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by IKFE Institute for Clinical Research and Development at 2 sites in Germany.
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 4 inclusion and 5 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation) (time frame: 4 weeks). 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 1 Apr 2015.