Diabetes MellitusPhase 4NCT00306696
Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
A Phase 4 study testing Rosiglitazone, spironolactone and hydrochlorothiazide in people with Diabetes Mellitus, run by GlaxoSmithKline at 46 sites in 14 countries.
Trial summary
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Rosiglitazone, spironolactone and hydrochlorothiazide
- How many people
- 388 participants
- Where
- 46 sitesin 14 countries
- Study dates
- Oct 2002to Jan 2004
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes.
- Stable FPG of >=7.0 and <=12.0mmol/L.
- Subjects had to have been established on SU treatment or SU+MET treatment for at least 2 months.
- Serum creatinine level > 130 micromol/L.
Who cannot join
- Subjects taking > 2 concomitant oral anti-diabetic agents.
- Subjects with HbA1c >=10%.
- Subjects already receiving diuretic medication.
- Subjects unstable or severe angina.
- CHF NYHA class i-iv.
- Subjects with clinically significant hepatic disease.
Trial locations and contacts
46 sites in 14 countries.
46 sites in 14 countries
Germany8 sites
GSK Investigational Site
Blieskastel, Saarland, 66440
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Munich, Bavaria, 80636
GSK Investigational Site
Munich, Bavaria, 80805
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460
Spain6 sites
GSK Investigational Site
Alicante
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08097
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Tarrasa, Barcelona, 08221
Italy5 sites
GSK Investigational Site
Acquavive Delle Fonti (BA), Apulia, 70021
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 21045
GSK Investigational Site
Perugia, Umbria, 06126
Poland5 sites
GSK Investigational Site
Bialystok, 15-276
GSK Investigational Site
Krakow, 31-501
GSK Investigational Site
Lodz, 90-153
GSK Investigational Site
Olsztyn
GSK Investigational Site
Warsaw, 03-242
Denmark3 sites
GSK Investigational Site
Aarhus, DK-8000
GSK Investigational Site
Hellerup, 2900
GSK Investigational Site
Hvidovre, DK-2650
Greece3 sites
GSK Investigational Site
Athens, 10676
GSK Investigational Site
N. Efkarpia, Thessaloniki, 564 29
GSK Investigational Site
Nikaia Piraeus, 184 54
Norway3 sites
GSK Investigational Site
Oslo
GSK Investigational Site
Stavanger, N-4011
GSK Investigational Site
Tromsø
Slovakia3 sites
GSK Investigational Site
Bratislava, 813 69
GSK Investigational Site
Košice, 041 90
GSK Investigational Site
Ľubochňa, 034 91
United Kingdom3 sites
GSK Investigational Site
London
GSK Investigational Site
Newcastle upon Tyne, Northumberland
GSK Investigational Site
Rugby, Warwickshire, CV22 5PX
Belgium2 sites
GSK Investigational Site
Brussels, 1090
GSK Investigational Site
Sint-Gillis-Waas, 9170
France2 sites
GSK Investigational Site
Dommartin-lès-Toul, 54201
GSK Investigational Site
Paris, 75877
About this study
Official title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Read the detailed description
A randomised, open-label, parallel group study to evaluate the management of rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone 4mg bd in addition to background anti-diabetic agents.
- Conditions
- Diabetes Mellitus
- Being tested
- Rosiglitazone, spironolactone, hydrochlorothiazide, frusemide
- Keywords
- rosiglitazone, fluid retention, Type 2 diabetes, diuretics
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
spironolactoneDrug
hydrochlorothiazideDrug
frusemideDrug
Also called spironolactone, hydrochlorothiazide, Rosiglitazone
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Haematocrit following 7 days diuretic adminstration.
Secondary outcomes (1)
Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startOct 2002
- Study completionJan 2004
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306696
- Sponsor's protocol ID
- 49653/342
- Status last verified
- Sep 2016
- First submitted
- 22 Mar 2006
- Last updated
- 15 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR
Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. doi: 10.1681/ASN.2006060606. Epub 2006 Nov 8.
PubMed 17093067
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia
- ClinicalTrials.gov ID
- NCT00306696
- Acronym / sponsor ID
- 49653/342
- Conditions
- Diabetes Mellitus
- Keywords
- rosiglitazone, fluid retention, Type 2 diabetes, diuretics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Jan 2004 (actual)
- First posted
- 24 Mar 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.
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Detailed description
A randomised, open-label, parallel group study to evaluate the management of rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone 4mg bd in addition to background anti-diabetic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with type 2 diabetes.
- Stable FPG of >=7.0 and <=12.0mmol/L.
- Subjects had to have been established on SU treatment or SU+MET treatment for at least 2 months.
- Serum creatinine level > 130 micromol/L.
Key exclusion criteria (6 listed)
- Subjects taking > 2 concomitant oral anti-diabetic agents.
- Subjects with HbA1c >=10%.
- Subjects already receiving diuretic medication.
- Subjects unstable or severe angina.
- CHF NYHA class i-iv.
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 | – |
| spironolactone | Drug | – |
| hydrochlorothiazide | Drug | – |
| frusemideAlso: spironolactone, hydrochlorothiazide, Rosiglitazone | Drug | – |
Primary outcome
Changes in Haematocrit following 7 days diuretic adminstration.
1 secondary outcome
Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
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 15 Sep 2016.
- Results publicationKaralliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR
- Results publication: PubMed 17093067Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. doi: 10.1681/ASN.2006060606. Epub 2006 Nov 8.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
46 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone, spironolactone and hydrochlorothiazide in people with Diabetes Mellitus, run by GlaxoSmithKline at 46 sites in 14 countries.
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 6 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Germany, Spain, Italy, Poland, Denmark and 9 more countries. 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?
Changes in Haematocrit following 7 days diuretic adminstration.. 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 NCT00306696, 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 15 Sep 2016.