Type 2 Diabetes MellitusPhase 4NCT00373178
Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
A Phase 4 study testing rosiglitazone, metformin and Anti-diabetic medications in people with Type 2 Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- rosiglitazone, metformin and Anti-diabetic medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2005to Jun 2008
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnosed type 2 diabetes
- No previous anti-diabetic medications
Who cannot join
- Heart failure
- Renal disease
- Liver disease
- Life-threatening diseases
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
AHEPA University Hospital of Thessaloniki
Thessaloniki
Aristotle University of Thessaloniki
Thessaloniki
About this study
The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- rosiglitazone, metformin, Anti-diabetic medications
- Keywords
- rosiglitazone, metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
metforminDrug
Anti-diabetic medicationsDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin,lifestyle counselling | Active comparator | Not described Receives: Drug: rosiglitazone; Drug: metformin; Drug: Anti-diabetic medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel cardiovascular risk factors modification
Measured: 2 years
Secondary outcomes (1)
Lipid and glucose regulation
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 posted7 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Principal investigator, Nikolaos Kadoglou, Aristotle University Of Thessaloniki
- Investigators
- Miltiadis Alevizos, PhD, Study chair, University Hospital AHEPA,Thessaloniki,Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373178
- Sponsor's protocol ID
- 020401975
- Status last verified
- Nov 2012
- First submitted
- 6 Sep 2006
- Last updated
- 2 Nov 2012
- Results posted
- No
Publications
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PubMed 32501595Kadoglou NP, Tsanikidis H, Kapelouzou A, Vrabas I, Vitta I, Karayannacos PE, Liapis CD, Sailer N. Effects of rosiglitazone and metformin treatment on apelin, visfatin, and ghrelin levels in patients with type 2 diabetes mellitus. Metabolism. 2010 Mar;59(3):373-9. doi: 10.1016/j.metabol.2009.08.005. Epub 2009 Oct 7.
PubMed 19815243
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00373178
- Acronym / sponsor ID
- 020401975
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- rosiglitazone, metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Sep 2006 (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 aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin,lifestyle counselling | Active comparator | Drug: rosiglitazone, Drug: metformin, Drug: Anti-diabetic medications |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recently diagnosed type 2 diabetes
- No previous anti-diabetic medications
Key exclusion criteria (4 listed)
- Heart failure
- Renal disease
- Liver disease
- Life-threatening diseases
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 |
|---|---|---|
| rosiglitazone | Drug | Metformin,lifestyle counselling |
| metformin | Drug | Metformin,lifestyle counselling |
| Anti-diabetic medications | Drug | Metformin,lifestyle counselling |
Primary outcome
Novel cardiovascular risk factors modification
Time frame: 2 years
1 secondary outcome
Lipid and glucose regulation
Time frame: 2 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 2 Nov 2012.
- Derived from this study: PubMed 32501595Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
- Derived from this study: PubMed 19815243Kadoglou NP, Tsanikidis H, Kapelouzou A, Vrabas I, Vitta I, Karayannacos PE, Liapis CD, Sailer N. Effects of rosiglitazone and metformin treatment on apelin, visfatin, and ghrelin levels in patients with type 2 diabetes mellitus. Metabolism. 2010 Mar;59(3):373-9. doi: 10.1016/j.metabol.2009.08.005. Epub 2009 Oct 7.
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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.
Miltiadis Alevizos, PhD study chair
University Hospital AHEPA,Thessaloniki,Greece
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 rosiglitazone, metformin and Anti-diabetic medications in people with Type 2 Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 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 2 Nov 2012. 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 Greece. 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?
Novel cardiovascular risk factors modification (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373178, which also lists 2 linked publications.
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 2 Nov 2012.