Type 2 DiabetesNCT01424891
Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
A study testing Simvastatin 80 mg and Sim10/Eze10 in people with Type 2 Diabetes and Inflammation, run by Heidelberg University at 1 site in Germany.
Trial summary
Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Inflammation
- What is being tested?
- Simvastatin 80 mg and Sim10/Eze10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Aug 2011
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 to 80 years old
- type 2 diabetes
- HbA1c value between 6.0 % and 9.0 %
- elevated LDL-c values > 100 mg/dl with no lipid lowering treatment within the last six month
Who cannot join
- refused informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes, Inflammation
- Being tested
- Simvastatin 80 mg, Sim10/Eze10, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 80 mgDrug
Also called zocor, simvastatin
treatment with 80 mg of simvastatin over a period of 8 weeks
Sim10/Eze10Drug
Also called inegy
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
PlaceboDrug
treatment with placebo over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Treatment with placebo over 8 weeks Receives: Drug: Placebo |
| Simvastatin 80 mg | Active comparator | treatment with 80 mg of simvastatin over 8 weeks Receives: Drug: Simvastatin 80 mg |
| Sim10/Eze10 | Active comparator | treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks Receives: Drug: Sim10/Eze10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
NF-kappa B binding activity
The binding activity of nuclear transcription factor nuclear factor kappa B (NF-kappa B)will be measured in patients with type 2 diabetes before and after 8 weeks while under study treatment. Analysis will be done with electrophoretic mobility shift assay. Nuclear extract, which is necessary, will be generated from peripheral blood mononuclear cells.
Measured: up to 5 years
Secondary outcomes (1)
Inflammatory markers
Blood levels of high sensitivity CRP and interleukin-6 will be measured before study start and after 8 weeks while under study medication.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startApr 2004
- Primary completionJul 2006
- Study completionAug 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gottfried Rudofsky, Heidelberg University
- Investigators
- Gottfried Rudofsky, MD, Principal investigator, University Hospital of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424891
- Sponsor's protocol ID
- SimEze
- Status last verified
- Aug 2011
- First submitted
- 23 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe
- ClinicalTrials.gov ID
- NCT01424891
- Acronym / sponsor ID
- SimEze
- Conditions
- Type 2 Diabetes, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Aug 2011 (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.
Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo over 8 weeks |
| Simvastatin 80 mg | Active comparator | Drug: Simvastatin 80 mgtreatment with 80 mg of simvastatin over 8 weeks |
| Sim10/Eze10 | Active comparator | Drug: Sim10/Eze10treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 35 to 80 years old
- type 2 diabetes
- HbA1c value between 6.0 % and 9.0 %
- elevated LDL-c values > 100 mg/dl with no lipid lowering treatment within the last six month
Key exclusion criteria (1 listed)
- refused informed consent
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 |
|---|---|---|
| Simvastatin 80 mgAlso: zocor, simvastatintreatment with 80 mg of simvastatin over a period of 8 weeks | Drug | Simvastatin 80 mg |
| Sim10/Eze10Also: inegytreatment with combination of simvastatin 10 mg and ezetimibe 10 mg | Drug | Sim10/Eze10 |
| Placebotreatment with placebo over 8 weeks | Drug | Placebo |
Primary outcome
NF-kappa B binding activity
Time frame: up to 5 years
The binding activity of nuclear transcription factor nuclear factor kappa B (NF-kappa B)will be measured in patients with type 2 diabetes before and after 8 weeks while under study treatment. Analysis will be done with electrophoretic mobility shift assay. Nuclear extract, which is necessary, will be generated from peripheral blood mononuclear cells.
1 secondary outcome
Inflammatory markers
Time frame: up to 5 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 29 Aug 2011.
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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.
Gottfried Rudofsky, MD principal investigator
University Hospital of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin 80 mg and Sim10/Eze10 in people with Type 2 Diabetes and Inflammation, run by Heidelberg University at 1 site 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 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 29 Aug 2011. 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 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. Some participants in this study may receive a placebo. 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?
NF-kappa B binding activity (time frame: up to 5 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 29 Aug 2011.