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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00306696 |
Purpose
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Insulin-Dependent Diabetes Mellitus |
Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | See Detailed Description |
| Estimated Enrollment: | 388 |
| Study Start Date: | October 2002 |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| Belgium | |
| GSK Investigational Site | |
| Brussel, Belgium, 1090 | |
| GSK Investigational Site | |
| Sint Gillis-Waas, Belgium, 9170 | |
| Canada, Manitoba | |
| GSK Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Denmark | |
| GSK Investigational Site | |
| Aarhus, Denmark, DK-8000 | |
| GSK Investigational Site | |
| Hellerup, Denmark, 2900 | |
| France | |
| GSK Investigational Site | |
| Paris Cedex 18, France, 75877 | |
| GSK Investigational Site | |
| Dommartin-Les Toul, France, 54201 | |
| Germany, Baden-Wuerttemberg | |
| GSK Investigational Site | |
| Heidelberg, Baden-Wuerttemberg, Germany, 69115 | |
| Germany, Bayern | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80805 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80636 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81241 | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | |
| Neuss, Nordrhein-Westfalen, Germany, 41460 | |
| Germany, Rheinland-Pfalz | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55116 | |
| Germany, Saarland | |
| GSK Investigational Site | |
| Blieskastel, Saarland, Germany, 66440 | |
| Germany, Sachsen | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01307 | |
| Greece | |
| GSK Investigational Site | |
| N. Efkarpia, Thessaloniki, Greece, 564 29 | |
| GSK Investigational Site | |
| Nikaia Piraeus, Greece, 184 54 | |
| GSK Investigational Site | |
| Athens, Greece, 10676 | |
| Israel | |
| GSK Investigational Site | |
| Jerusalem, Israel | |
| Italy, Emilia-Romagna | |
| GSK Investigational Site | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Italy, Liguria | |
| GSK Investigational Site | |
| Genova, Liguria, Italy, 16132 | |
| Italy, Lombardia | |
| GSK Investigational Site | |
| Milano, Lombardia, Italy, 21045 | |
| Italy, Puglia | |
| GSK Investigational Site | |
| Acquavive delle Fonti (BA), Puglia, Italy, 70021 | |
| Italy, Umbria | |
| GSK Investigational Site | |
| Perugia, Umbria, Italy, 06126 | |
| Netherlands | |
| GSK Investigational Site | |
| UTRECHT, Netherlands, 3584 CJ | |
| Norway | |
| GSK Investigational Site | |
| Stavanger, Norway, N-4011 | |
| GSK Investigational Site | |
| Tromsoe, Norway | |
| GSK Investigational Site | |
| Oslo, Norway | |
| Poland | |
| GSK Investigational Site | |
| Bialystok, Poland, 15-276 | |
| GSK Investigational Site | |
| Krakow, Poland, 31-501 | |
| GSK Investigational Site | |
| Olsztyn, Poland | |
| GSK Investigational Site | |
| Warszawa, Poland, 03-242 | |
| Slovakia | |
| GSK Investigational Site | |
| Lubochna, Slovakia, 034 91 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 813 69 | |
| GSK Investigational Site | |
| Kosice, Slovakia, 041 90 | |
| Spain | |
| GSK Investigational Site | |
| Madrid, Spain, 28040 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08022 | |
| GSK Investigational Site | |
| Madrid, Spain, 28035 | |
| GSK Investigational Site | |
| Alicante, Spain | |
| GSK Investigational Site | |
| Tarrasa, Barcelona, Spain, 08221 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08097 | |
| United Kingdom | |
| GSK Investigational Site | |
| London, United Kingdom | |
| United Kingdom, Northumberland | |
| GSK Investigational Site | |
| Newcastle Upon Tyne, Northumberland, United Kingdom | |
| United Kingdom, Warwickshire | |
| GSK Investigational Site | |
| Rugby, Warwickshire, United Kingdom, CV22 5PX | |
| Study Director: | GSK Clinical Trials, DM, FRCP | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 49653/342 |
| Study First Received: | March 22, 2006 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00306696 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Type 2 diabetes rosiglitazone diuretics fluid retention |
|
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Hormone Antagonists Sodium Chloride Symporter Inhibitors Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Furosemide |
Hydrochlorothiazide Pharmacologic Actions Spironolactone Membrane Transport Modulators Hypoglycemic Agents Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Sodium Potassium Chloride Symporter Inhibitors Glucose Metabolism Disorders Rosiglitazone |
