Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Phase 3

Terminated

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

• Registration Number: NCT00361868
• Lead Sponsor: Solvay Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-08
• Study First Posted: 2006-08-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-26
• Last Update Posted: 2008-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

Exclusion Criteria

• Type 1 diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c/TG	24 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid and glycemic parameters.	24 weeks

Trial Locations

Locations (70)

Site 405; 🇩🇪 Berlin, Germany

Site105; 🇭🇷 Pula, Croatia

Site102; 🇭🇷 Rijeka, Croatia

Site 404; 🇩🇪 Frankfurt, Germany

Site 413; 🇩🇪 Rotenburg, Germany

Site 401; 🇩🇪 Hannover, Germany

Site 407; 🇩🇪 Leipzig, Germany

Site 402; 🇩🇪 Dresden, Germany

Site 502; 🇳🇱 Breda, Netherlands

Site 406; 🇩🇪 Rodgau, Germany

Site 412; 🇩🇪 Villingen-Schwenningen, Germany

Site 307; 🇫🇷 Bordeaux, France

Site 305; 🇫🇷 Murs Erigne, France

Site 304; 🇫🇷 Strasbourg, France

Site 411; 🇩🇪 Ilvesheim, Germany

Site 509; 🇳🇱 Almere, Netherlands

Site 400; 🇩🇪 Freiburg, Germany

Site 403; 🇩🇪 Bretten, Germany

Site 507; 🇳🇱 Velp, Netherlands

Site 607; 🇵🇱 Warszawa, Poland

Site 612; 🇵🇱 Warszawa, Poland

Site 303; 🇫🇷 Bassens, France

Site 302; 🇫🇷 Seysses, France

Site 306; 🇫🇷 Vihiers, France

Site 408; 🇩🇪 Schwerin, Germany

Site 206; 🇫🇮 Kokkola, Finland

Site100; 🇭🇷 Zagreb, Croatia

Site 409; 🇩🇪 Ilvesheim, Germany

Site 410; 🇩🇪 Borna, Germany

Site 207; 🇫🇮 Oulu, Finland

Site 301; 🇫🇷 Thouars, France

Site 610; 🇵🇱 Bialystok, Poland

Site 812; 🇺🇦 Kharkiv, Ukraine

Site 605; 🇵🇱 Otolinska, Poland

Site104; 🇭🇷 Varazdin, Croatia

Site101; 🇭🇷 Zagreb, Croatia

Site 205; 🇫🇮 Jyväskylä, Finland

Site 703; 🇷🇴 Bucharest, Romania

Site 810; 🇺🇦 Kiev, Ukraine

Site 813; 🇺🇦 Kiev, Ukraine

Site 802; 🇺🇦 Vinnitsa, Ukraine

Site 503; 🇳🇱 Eindhoven, Netherlands

Site 604; 🇵🇱 Radom, Poland

Site103; 🇭🇷 Split, Croatia

Site 504; 🇳🇱 Groningen, Netherlands

Site 505; 🇳🇱 Leiden, Netherlands

Site 508; 🇳🇱 Zoetermeer, Netherlands

Site 702; 🇷🇴 Iasi, Romania

Site 705; 🇷🇴 Targu-Mures, Romania

Site 807; 🇺🇦 Kharkiv, Ukraine

Site 800; 🇺🇦 Kiev, Ukraine

Site 701; 🇷🇴 Bucharest, Romania

Site 208; 🇫🇮 Laukaa, Finland

Site 600; 🇵🇱 Lodz, Poland

Site 811; 🇺🇦 Kharkiv, Ukraine

Site 808; 🇺🇦 Kiev, Ukraine

Site 506; 🇳🇱 Nijmegen, Netherlands

Site 500; 🇳🇱 Rotterdam, Netherlands

Site 606; 🇵🇱 Elblag, Poland

Site 608; 🇵🇱 Gdansk, Poland

Site 613; 🇵🇱 Starogard Gdanski, Poland

Site 601; 🇵🇱 Warszawa, Poland

Site 704; 🇷🇴 Brasov, Romania

Site 803; 🇺🇦 Kiev, Ukraine

Site 602; 🇵🇱 Wroclaw, Poland

Site 603; 🇵🇱 Wroclaw, Poland

Site 700; 🇷🇴 Cluj-Napoca, Romania

Site 809; 🇺🇦 Kiev, Ukraine

Site 805; 🇺🇦 Lviv, Ukraine

Site 804; 🇺🇦 Odessa, Ukraine