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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-006060-63 |
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The study was discontinued prematurely at the end of March 2007 due to slow enrolment.
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Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate (F) + metformin (M) hydrochloride fixed combination | Drug | First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c/TG | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid and glycemic parameters. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site105 | Pula | Croatia | ||||
| Site102 |
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| Rosiglitazone | Drug | First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks |
|
| Rijeka |
| Croatia |
| Site103 | Split | Croatia |
| Site104 | Varaždin | Croatia |
| Site100 | Zagreb | Croatia |
| Site101 | Zagreb | Croatia |
| Site 205 | Jyväskylä | Finland |
| Site 206 | Kokkola | Finland |
| Site 208 | Laukaa | Finland |
| Site 207 | Oulu | Finland |
| Site 303 | Bassens | France |
| Site 307 | Bordeaux | France |
| Site 305 | Mûrs-Erigné | France |
| Site 302 | Seysses | France |
| Site 304 | Strasbourg | France |
| Site 301 | Thouars | France |
| Site 306 | Vihiers | France |
| Site 405 | Berlin | Germany |
| Site 410 | Borna | Germany |
| Site 403 | Bretten | Germany |
| Site 402 | Dresden | Germany |
| Site 404 | Frankfurt | Germany |
| Site 400 | Freiburg im Breisgau | Germany |
| Site 401 | Hanover | Germany |
| Site 409 | Ilvesheim | Germany |
| Site 411 | Ilvesheim | Germany |
| Site 407 | Leipzig | Germany |
| Site 406 | Rodgau | Germany |
| Site 413 | Rotenburg (Wümme) | Germany |
| Site 408 | Schwerin | Germany |
| Site 412 | Villingen-Schwenningen | Germany |
| Site 509 | Almere Stad | Netherlands |
| Site 502 | Breda | Netherlands |
| Site 503 | Eindhoven | Netherlands |
| Site 504 | Groningen | Netherlands |
| Site 505 | Leiden | Netherlands |
| Site 506 | Nijmegen | Netherlands |
| Site 500 | Rotterdam | Netherlands |
| Site 507 | Velp | Netherlands |
| Site 508 | Zoetermeer | Netherlands |
| Site 610 | Bialystok | Poland |
| Site 606 | Elblag | Poland |
| Site 608 | Gdansk | Poland |
| Site 600 | Lodz | Poland |
| Site 605 | Otolinska | Poland |
| Site 604 | Radom | Poland |
| Site 613 | Starogard Gdański | Poland |
| Site 601 | Warsaw | Poland |
| Site 607 | Warsaw | Poland |
| Site 612 | Warsaw | Poland |
| Site 602 | Wroclaw | Poland |
| Site 603 | Wroclaw | Poland |
| Site 704 | Brasov | Romania |
| Site 701 | Bucharest | Romania |
| Site 703 | Bucharest | Romania |
| Site 700 | Cluj-Napoca | Romania |
| Site 702 | Iași | Romania |
| Site 705 | Târgu Mureş | Romania |
| Site 807 | Kharkiv | Ukraine |
| Site 811 | Kharkiv | Ukraine |
| Site 812 | Kharkiv | Ukraine |
| Site 800 | Kiev | Ukraine |
| Site 803 | Kiev | Ukraine |
| Site 808 | Kiev | Ukraine |
| Site 809 | Kiev | Ukraine |
| Site 810 | Kiev | Ukraine |
| Site 813 | Kiev | Ukraine |
| Site 805 | Lviv | Ukraine |
| Site 804 | Odesa | Ukraine |
| Site 802 | Vinnitsa | Ukraine |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D008687 | Metformin |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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