Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00361868
Collaborator
(none)
88
70
2
18
1.3
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia
Study Start Date
:
Jun 1, 2006
Actual Primary Completion Date
:
Dec 1, 2007
Actual Study Completion Date
:
Dec 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
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
|
| Active Comparator: 2
|
Drug: Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
|
Outcome Measures
Primary Outcome Measures
- HbA1c/TG [24 weeks]
Secondary Outcome Measures
- Lipid and glycemic parameters. [24 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.
Exclusion Criteria:
- Type 1 diabetes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site105 | Pula | Croatia | ||
| 2 | Site102 | Rijeka | Croatia | ||
| 3 | Site103 | Split | Croatia | ||
| 4 | Site104 | Varazdin | Croatia | ||
| 5 | Site100 | Zagreb | Croatia | ||
| 6 | Site101 | Zagreb | Croatia | ||
| 7 | Site 205 | Jyväskylä | Finland | ||
| 8 | Site 206 | Kokkola | Finland | ||
| 9 | Site 208 | Laukaa | Finland | ||
| 10 | Site 207 | Oulu | Finland | ||
| 11 | Site 303 | Bassens | France | ||
| 12 | Site 307 | Bordeaux | France | ||
| 13 | Site 305 | Murs Erigne | France | ||
| 14 | Site 302 | Seysses | France | ||
| 15 | Site 304 | Strasbourg | France | ||
| 16 | Site 301 | Thouars | France | ||
| 17 | Site 306 | Vihiers | France | ||
| 18 | Site 405 | Berlin | Germany | ||
| 19 | Site 410 | Borna | Germany | ||
| 20 | Site 403 | Bretten | Germany | ||
| 21 | Site 402 | Dresden | Germany | ||
| 22 | Site 404 | Frankfurt | Germany | ||
| 23 | Site 400 | Freiburg | Germany | ||
| 24 | Site 401 | Hannover | Germany | ||
| 25 | Site 409 | Ilvesheim | Germany | ||
| 26 | Site 411 | Ilvesheim | Germany | ||
| 27 | Site 407 | Leipzig | Germany | ||
| 28 | Site 406 | Rodgau | Germany | ||
| 29 | Site 413 | Rotenburg | Germany | ||
| 30 | Site 408 | Schwerin | Germany | ||
| 31 | Site 412 | Villingen-Schwenningen | Germany | ||
| 32 | Site 509 | Almere | Netherlands | ||
| 33 | Site 502 | Breda | Netherlands | ||
| 34 | Site 503 | Eindhoven | Netherlands | ||
| 35 | Site 504 | Groningen | Netherlands | ||
| 36 | Site 505 | Leiden | Netherlands | ||
| 37 | Site 506 | Nijmegen | Netherlands | ||
| 38 | Site 500 | Rotterdam | Netherlands | ||
| 39 | Site 507 | Velp | Netherlands | ||
| 40 | Site 508 | Zoetermeer | Netherlands | ||
| 41 | Site 610 | Bialystok | Poland | ||
| 42 | Site 606 | Elblag | Poland | ||
| 43 | Site 608 | Gdansk | Poland | ||
| 44 | Site 600 | Lodz | Poland | ||
| 45 | Site 605 | Otolinska | Poland | ||
| 46 | Site 604 | Radom | Poland | ||
| 47 | Site 613 | Starogard Gdanski | Poland | ||
| 48 | Site 601 | Warszawa | Poland | ||
| 49 | Site 607 | Warszawa | Poland | ||
| 50 | Site 612 | Warszawa | Poland | ||
| 51 | Site 602 | Wroclaw | Poland | ||
| 52 | Site 603 | Wroclaw | Poland | ||
| 53 | Site 704 | Brasov | Romania | ||
| 54 | Site 701 | Bucharest | Romania | ||
| 55 | Site 703 | Bucharest | Romania | ||
| 56 | Site 700 | Cluj-Napoca | Romania | ||
| 57 | Site 702 | Iasi | Romania | ||
| 58 | Site 705 | Targu-Mures | Romania | ||
| 59 | Site 807 | Kharkiv | Ukraine | ||
| 60 | Site 811 | Kharkiv | Ukraine | ||
| 61 | Site 812 | Kharkiv | Ukraine | ||
| 62 | Site 800 | Kiev | Ukraine | ||
| 63 | Site 803 | Kiev | Ukraine | ||
| 64 | Site 808 | Kiev | Ukraine | ||
| 65 | Site 809 | Kiev | Ukraine | ||
| 66 | Site 810 | Kiev | Ukraine | ||
| 67 | Site 813 | Kiev | Ukraine | ||
| 68 | Site 805 | Lviv | Ukraine | ||
| 69 | Site 804 | Odessa | Ukraine | ||
| 70 | Site 802 | Vinnitsa | Ukraine |
Sponsors and Collaborators
- Solvay Pharmaceuticals
Investigators
- Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00361868
Other Study ID Numbers:
- C LF23-0121 05 01
- 2005-006060-63
First Posted:
Aug 9, 2006
Last Update Posted:
Jun 27, 2008
Last Verified:
Jun 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: