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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000924-15 |
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To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C
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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 | F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TG / HDL-C ratio | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid and glycemic parameters | 24 weeks |
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Inclusion Criteria Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment.
Exclusion Criteria Type 1 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Michel Conte | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C LF23-0121 06 01 Site107 | Brno | Czechia | ||||
| C LF23-0121 06 01 Site108 |
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| Metformin | Drug | 500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks |
|
| Holešov |
| Czechia |
| C LF23-0121 06 01 Site101 | Karlovy Vary | Czechia |
| C LF23-0121 06 01 Site106 | Olomouc | Czechia |
| C LF23-0121 06 01 Site109 | Olomouc | Czechia |
| C LF23-0121 06 01 Site103 | Pardubice | Czechia |
| C LF23-0121 06 01 Site102 | Prague | Czechia |
| C LF23-0121 06 01 Site104 | Prague | Czechia |
| C LF23-0121 06 01 Site105 | Prague | Czechia |
| C LF23-0121 06 01 Site 204 | Bailleul | France |
| C LF23-0121 06 01 Site 200 | Bondy | France |
| C LF23-0121 06 01 Site 207 | Cholet | France |
| C LF23-0121 06 01 Site 208 | Évreux | France |
| C LF23-0121 06 01 Site 201 | Pantin | France |
| C LF23-0121 06 01 Site 202 | Tours | France |
| C LF23-0121 06 01 Site 205 | Wattrelos | France |
| C LF23-0121 06 01 Site 406 | Balatonfüred | Hungary |
| C LF23-0121 06 01 Site 400 | Budapest | Hungary |
| C LF23-0121 06 01 Site 401 | Budapest | Hungary |
| C LF23-0121 06 01 Site 402 | Budapest | Hungary |
| C LF23-0121 06 01 Site 403 | Budapest | Hungary |
| C LF23-0121 06 01 Site 405 | Budapest | Hungary |
| C LF23-0121 06 01 Site 407 | Budapest | Hungary |
| C LF23-0121 06 01 Site 408 | Budapest | Hungary |
| C LF23-0121 06 01 Site 404 | Debrecen | Hungary |
| C LF23-0121 06 01 Site 501 | Bangalore | India |
| C LF23-0121 06 01 Site 504 | Bangalore | India |
| C LF23-0121 06 01 Site 516 | Bangalore | India |
| C LF23-0121 06 01 Site 519 | Bangalore | India |
| C LF23-0121 06 01 Site 508 | Chennai | India |
| C LF23-0121 06 01 Site 510 | Chennai | India |
| C LF23-0121 06 01 Site 505 | Hyderabad | India |
| C LF23-0121 06 01 Site 509 | Hyderabad | India |
| C LF23-0121 06 01 Site 517 | Hyderabad | India |
| C LF23-0121 06 01 Site 511 | Karnataka | India |
| C LF23-0121 06 01 Site 512 | Maharashtra | India |
| C LF23-0121 06 01 Site 502 | Mumbai | India |
| C LF23-0121 06 01 Site 503 | Mumbai | India |
| C LF23-0121 06 01 Site 518 | Nashik | India |
| C LF23-0121 06 01 Site 506 | Pune | India |
| C LF23-0121 06 01 Site 514 | Tiruvanathapuram-Kerala | India |
| C LF23-0121 06 01 Site 800 | Vilnius | Lithuania |
| C LF23-0121 06 01 Site 801 | Vilnius | Lithuania |
| C LF23-0121 06 01 Site 802 | Vilnius | Lithuania |
| C LF23-0121 06 01 Site 600 | Bialystok | Poland |
| C LF23-0121 06 01 Site 613 | Bydgoszcz | Poland |
| C LF23-0121 06 01 Site 618 | Grudziądz | Poland |
| C LF23-0121 06 01 Site 603 | Katowice | Poland |
| C LF23-0121 06 01 Site 601 | Krakow | Poland |
| C LF23-0121 06 01 Site 607 | Krakow | Poland |
| C LF23-0121 06 01 Site 610 | Krakow | Poland |
| C LF23-0121 06 01 Site 615 | Kutno | Poland |
| C LF23-0121 06 01 Site 605 | Olsztyn | Poland |
| C LF23-0121 06 01 Site 604 | Opole | Poland |
| C LF23-0121 06 01 Site 606 | Poznan | Poland |
| C LF23-0121 06 01 Site 609 | Poznan | Poland |
| C LF23-0121 06 01 Site 621 | Sliwinska | Poland |
| C LF23-0121 06 01 Site 617 | Starogard Gdański | Poland |
| C LF23-0121 06 01 Site 616 | Szczecin | Poland |
| C LF23-0121 06 01 Site 602 | Warsaw | Poland |
| C LF23-0121 06 01 Site 608 | Warsaw | Poland |
| C LF23-0121 06 01 Site 619 | Warsaw | Poland |
| C LF23-0121 06 01 Site 620 | Warsaw | Poland |
| C LF23-0121 06 01 Site 611 | Wroclaw | Poland |
| C LF23-0121 06 01 Site 612 | Wroclaw | Poland |
| C LF23-0121 06 01 Site 614 | Zgierz | Poland |
| C LF23-0121 06 01 Site 700 | Bratislava | Slovakia |
| C LF23-0121 06 01 Site 703 | Košice | Slovakia |
| C LF23-0121 06 01 Site 702 | Lučenec | Slovakia |
| C LF23-0121 06 01 Site 701 | Skalica | Slovakia |
| 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 |
| 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 |
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