Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

NCT00361868 | Terminated Phase 3 DMC

• 2 other identifiers: C LF23-0121 05 012005-006060-63
• Study Type: interventional
• Target: 88
• Locations: 8 countries
• Sites: 70

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.

Conditions

Dyslipidemia; Glucose Metabolism Disorder

Keywords

Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c/TG

  24 weeks

Secondary Outcomes (1)

• Lipid and glycemic parameters.

  24 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination

2

ACTIVE COMPARATOR

Drug: Rosiglitazone

Interventions

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

1

Rosiglitazone DRUG

First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 1 diabetes.

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (70)

Site105

Pula, Croatia

Location

Site102

Rijeka, Croatia

Location

Site103

Split, Croatia

Location

Site104

Varaždin, Croatia

Location

Site100

Zagreb, Croatia

Location

Site101

Zagreb, Croatia

Location

Site 205

Jyväskylä, Finland

Location

Site 206

Kokkola, Finland

Location

Site 208

Laukaa, Finland

Location

Site 207

Oulu, Finland

Location

Site 303

Bassens, France

Location

Site 307

Bordeaux, France

Location

Site 305

Mûrs-Erigné, France

Location

Site 302

Seysses, France

Location

Site 304

Strasbourg, France

Location

Site 301

Thouars, France

Location

Site 306

Vihiers, France

Location

Site 405

Berlin, Germany

Location

Site 410

Borna, Germany

Location

Site 403

Bretten, Germany

Location

Site 402

Dresden, Germany

Location

Site 404

Frankfurt, Germany

Location

Site 400

Freiburg im Breisgau, Germany

Location

Site 401

Hanover, Germany

Location

Site 409

Ilvesheim, Germany

Location

Site 411

Ilvesheim, Germany

Location

Site 407

Leipzig, Germany

Location

Site 406

Rodgau, Germany

Location

Site 413

Rotenburg (Wümme), Germany

Location

Site 408

Schwerin, Germany

Location

Site 412

Villingen-Schwenningen, Germany

Location

Site 509

Almere Stad, Netherlands

Location

Site 502

Breda, Netherlands

Location

Site 503

Eindhoven, Netherlands

Location

Site 504

Groningen, Netherlands

Location

Site 505

Leiden, Netherlands

Location

Site 506

Nijmegen, Netherlands

Location

Site 500

Rotterdam, Netherlands

Location

Site 507

Velp, Netherlands

Location

Site 508

Zoetermeer, Netherlands

Location

Site 610

Bialystok, Poland

Location

Site 606

Elblag, Poland

Location

Site 608

Gdansk, Poland

Location

Site 600

Lodz, Poland

Location

Site 605

Otolinska, Poland

Location

Site 604

Radom, Poland

Location

Site 613

Starogard Gdański, Poland

Location

Site 601

Warsaw, Poland

Location

Site 607

Warsaw, Poland

Location

Site 612

Warsaw, Poland

Location

Site 602

Wroclaw, Poland

Location

Site 603

Wroclaw, Poland

Location

Site 704

Brasov, Romania

Location

Site 701

Bucharest, Romania

Location

Site 703

Bucharest, Romania

Location

Site 700

Cluj-Napoca, Romania

Location

Site 702

Iași, Romania

Location

Site 705

Târgu Mureş, Romania

Location

Site 807

Kharkiv, Ukraine

Location

Site 811

Kharkiv, Ukraine

Location

Site 812

Kharkiv, Ukraine

Location

Site 800

Kiev, Ukraine

Location

Site 803

Kiev, Ukraine

Location

Site 808

Kiev, Ukraine

Location

Site 809

Kiev, Ukraine

Location

Site 810

Kiev, Ukraine

Location

Site 813

Kiev, Ukraine

Location

Site 805

Lviv, Ukraine

Location

Site 804

Odesa, Ukraine

Location

Site 802

Vinnitsa, Ukraine

Location

MeSH Terms

Conditions

Dyslipidemias; Glucose Metabolism Disorders

Interventions

Fenofibrate; Metformin; Rosiglitazone

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Biguanides; Guanidines; Amidines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 9, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

FR (7); FI (4); PL (12); CR (6); UA (12); NL (9); RO (6); DE (14)