Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Phase 3

Completed

• Conditions: Dyslipidemia/Glucose Metabolism Disorder
• Interventions: Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination; Drug: Metformin

• Registration Number: NCT00362323
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Study Start: 2006-10
• Primary Completion: 2008-08
• Study Completion: 2009-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-15
• Last Update Posted: 2010-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fenofibrate (F) + metformin (M) hydrochloride fixed combination	-
2	Metformin	-

Primary Outcome Measures

Name	Time	Method
TG / HDL-C ratio	24 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid and glycemic parameters	24 weeks

Trial Locations

Locations (70)

C LF23-0121 06 01 Site107; 🇨🇿 Brno, Czech Republic

C LF23-0121 06 01 Site108; 🇨🇿 Holesov, Czech Republic

C LF23-0121 06 01 Site106; 🇨🇿 Olomouc, Czech Republic

C LF23-0121 06 01 Site101; 🇨🇿 Karlovy Vary, Czech Republic

C LF23-0121 06 01 Site109; 🇨🇿 Olomouc, Czech Republic

C LF23-0121 06 01 Site103; 🇨🇿 Pardubice, Czech Republic

C LF23-0121 06 01 Site102; 🇨🇿 Praha, Czech Republic

C LF23-0121 06 01 Site104; 🇨🇿 Praha, Czech Republic

C LF23-0121 06 01 Site105; 🇨🇿 Praha, Czech Republic

C LF23-0121 06 01 Site 204; 🇫🇷 Bailleul, France

C LF23-0121 06 01 Site 200; 🇫🇷 Bondy, France

C LF23-0121 06 01 Site 201; 🇫🇷 Pantin, France

C LF23-0121 06 01 Site 207; 🇫🇷 Cholet, France

C LF23-0121 06 01 Site 208; 🇫🇷 Evreux, France

C LF23-0121 06 01 Site 205; 🇫🇷 Wattrelos, France

C LF23-0121 06 01 Site 202; 🇫🇷 Tours, 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 516; 🇮🇳 Bangalore, India

C LF23-0121 06 01 Site 501; 🇮🇳 Bangalore, India

C LF23-0121 06 01 Site 504; 🇮🇳 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 800; 🇱🇹 Vilnius, Lithuania

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 518; 🇮🇳 Nasik, India

C LF23-0121 06 01 Site 503; 🇮🇳 Mumbai, India

C LF23-0121 06 01 Site 514; 🇮🇳 Tiruvanathapuram-Kerala, India

C LF23-0121 06 01 Site 506; 🇮🇳 Pune, India

C LF23-0121 06 01 Site 801; 🇱🇹 Vilnius, Lithuania

C LF23-0121 06 01 Site 613; 🇵🇱 Bydgoszcz, Poland

C LF23-0121 06 01 Site 802; 🇱🇹 Vilnius, Lithuania

C LF23-0121 06 01 Site 600; 🇵🇱 Bialystok, Poland

C LF23-0121 06 01 Site 603; 🇵🇱 Katowice, Poland

C LF23-0121 06 01 Site 618; 🇵🇱 Grudziadz, Poland

C LF23-0121 06 01 Site 601; 🇵🇱 Kraków, Poland

C LF23-0121 06 01 Site 607; 🇵🇱 Kraków, Poland

C LF23-0121 06 01 Site 610; 🇵🇱 Kraków, 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 Gdanski, Poland

C LF23-0121 06 01 Site 616; 🇵🇱 Szczecin, Poland

C LF23-0121 06 01 Site 602; 🇵🇱 Warszawa, Poland

C LF23-0121 06 01 Site 608; 🇵🇱 Warszawa, Poland

C LF23-0121 06 01 Site 619; 🇵🇱 Warszawa, Poland

C LF23-0121 06 01 Site 620; 🇵🇱 Warszawa, Poland

C LF23-0121 06 01 Site 612; 🇵🇱 Wroclaw, Poland

C LF23-0121 06 01 Site 611; 🇵🇱 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; 🇸🇰 Kosice, Slovakia

C LF23-0121 06 01 Site 702; 🇸🇰 Lucenec, Slovakia

C LF23-0121 06 01 Site 701; 🇸🇰 Skalica, Slovakia