MedDataX Logo

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

NCT ID: NCT00362323

Last Updated: 2010-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acceptability of a Fixed Combination of Fenofibrate and Metformin

NCT00348725

Dyslipidemia/Glucose Metabolism Disorder
COMPLETED PHASE3

Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

NCT00362765

Type 2 Diabetes Dyslipidemia
TERMINATED PHASE2/PHASE3

Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

NCT00490178

Diabetes Mellitus, Type 2 Dyslipidemia
COMPLETED PHASE3

A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.

NCT00703755

Patients With Metabolic Syndrome
COMPLETED PHASE2

Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Participants

NCT05550129

Healthy Volunteers
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia/Glucose Metabolism Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

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

Intervention Type 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

2

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DRUG

Metformin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michel Conte

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

C LF23-0121 06 01 Site 516

Bangalore, , India

Site Status

C LF23-0121 06 01 Site 519

Bangalore, , India

Site Status

C LF23-0121 06 01 Site 508

Chennai, , India

Site Status

C LF23-0121 06 01 Site 510

Chennai, , India

Site Status

C LF23-0121 06 01 Site 505

Hyderabad, , India

Site Status

C LF23-0121 06 01 Site 509

Hyderabad, , India

Site Status

C LF23-0121 06 01 Site 517

Hyderabad, , India

Site Status

C LF23-0121 06 01 Site 511

Karnataka, , India

Site Status

C LF23-0121 06 01 Site 512

Maharashtra, , India

Site Status

C LF23-0121 06 01 Site 502

Mumbai, , India

Site Status

C LF23-0121 06 01 Site 503

Mumbai, , India

Site Status

C LF23-0121 06 01 Site 518

Nashik, , India

Site Status

C LF23-0121 06 01 Site 506

Pune, , India

Site Status

C LF23-0121 06 01 Site 514

Tiruvanathapuram-Kerala, , India

Site Status

C LF23-0121 06 01 Site 800

Vilnius, , Lithuania

Site Status

C LF23-0121 06 01 Site 801

Vilnius, , Lithuania

Site Status

C LF23-0121 06 01 Site 802

Vilnius, , Lithuania

Site Status

C LF23-0121 06 01 Site 600

Bialystok, , Poland

Site Status

C LF23-0121 06 01 Site 613

Bydgoszcz, , Poland

Site Status

C LF23-0121 06 01 Site 618

Grudziądz, , Poland

Site Status

C LF23-0121 06 01 Site 603

Katowice, , Poland

Site Status

C LF23-0121 06 01 Site 601

Krakow, , Poland

Site Status

C LF23-0121 06 01 Site 607

Krakow, , Poland

Site Status

C LF23-0121 06 01 Site 610

Krakow, , Poland

Site Status

C LF23-0121 06 01 Site102

Prague, , Czechia

Site Status

C LF23-0121 06 01 Site104

Prague, , Czechia

Site Status

C LF23-0121 06 01 Site105

Prague, , Czechia

Site Status

C LF23-0121 06 01 Site 204

Bailleul, , France

Site Status

C LF23-0121 06 01 Site 200

Bondy, , France

Site Status

C LF23-0121 06 01 Site 207

Cholet, , France

Site Status

C LF23-0121 06 01 Site 208

Évreux, , France

Site Status

C LF23-0121 06 01 Site 201

Pantin, , France

Site Status

C LF23-0121 06 01 Site 202

Tours, , France

Site Status

C LF23-0121 06 01 Site 205

Wattrelos, , France

Site Status

C LF23-0121 06 01 Site 406

Balatonfüred, , Hungary

Site Status

C LF23-0121 06 01 Site 400

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 401

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 402

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 403

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 405

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 407

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 408

Budapest, , Hungary

Site Status

C LF23-0121 06 01 Site 404

Debrecen, , Hungary

Site Status

C LF23-0121 06 01 Site 501

Bangalore, , India

Site Status

C LF23-0121 06 01 Site 504

Bangalore, , India

Site Status

C LF23-0121 06 01 Site107

Brno, , Czechia

Site Status

C LF23-0121 06 01 Site108

Holešov, , Czechia

Site Status

C LF23-0121 06 01 Site101

Karlovy Vary, , Czechia

Site Status

C LF23-0121 06 01 Site106

Olomouc, , Czechia

Site Status

C LF23-0121 06 01 Site109

Olomouc, , Czechia

Site Status

C LF23-0121 06 01 Site103

Pardubice, , Czechia

Site Status

C LF23-0121 06 01 Site 615

Kutno, , Poland

Site Status

C LF23-0121 06 01 Site 605

Olsztyn, , Poland

Site Status

C LF23-0121 06 01 Site 604

Opole, , Poland

Site Status

C LF23-0121 06 01 Site 606

Poznan, , Poland

Site Status

C LF23-0121 06 01 Site 609

Poznan, , Poland

Site Status

C LF23-0121 06 01 Site 621

Sliwinska, , Poland

Site Status

C LF23-0121 06 01 Site 617

Starogard Gdański, , Poland

Site Status

C LF23-0121 06 01 Site 616

Szczecin, , Poland

Site Status

C LF23-0121 06 01 Site 602

Warsaw, , Poland

Site Status

C LF23-0121 06 01 Site 608

Warsaw, , Poland

Site Status

C LF23-0121 06 01 Site 619

Warsaw, , Poland

Site Status

C LF23-0121 06 01 Site 620

Warsaw, , Poland

Site Status

C LF23-0121 06 01 Site 611

Wroclaw, , Poland

Site Status

C LF23-0121 06 01 Site 612

Wroclaw, , Poland

Site Status

C LF23-0121 06 01 Site 614

Zgierz, , Poland

Site Status

C LF23-0121 06 01 Site 700

Bratislava, , Slovakia

Site Status

C LF23-0121 06 01 Site 703

Košice, , Slovakia

Site Status

C LF23-0121 06 01 Site 702

Lučenec, , Slovakia

Site Status

C LF23-0121 06 01 Site 701

Skalica, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia France Hungary India Lithuania Poland Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-000924-15

Identifier Type: -

Identifier Source: secondary_id

C LF23-0121 06 01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
NCT01535677 COMPLETED PHASE1
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
NCT00736385 TERMINATED PHASE4
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
NCT01844531 COMPLETED PHASE1
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
NCT01809327 COMPLETED PHASE3
Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome
NCT02960711 COMPLETED PHASE3
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
NCT03355014 COMPLETED PHASE1
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin
NCT02053116 TERMINATED PHASE2
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
NCT00929201 COMPLETED PHASE1
Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
NCT02221180 COMPLETED PHASE1
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
NCT01662674 COMPLETED PHASE1
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
NCT02851212 COMPLETED PHASE1
Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs
NCT00491725 COMPLETED PHASE4
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
NCT02670018 UNKNOWN PHASE1
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes
NCT01720290 COMPLETED PHASE4
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.
NCT02056600 COMPLETED PHASE1
Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM
NCT01804842 COMPLETED PHASE1/PHASE2
Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers
NCT05124730 COMPLETED PHASE1
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
NCT06932874 RECRUITING PHASE4
Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
NCT01443221 COMPLETED PHASE1
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
NCT01463228 COMPLETED PHASE1
Metformin in Non-Alcoholic Fatty Liver Disease
NCT00303537 UNKNOWN PHASE2/PHASE3
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
NCT01747083 COMPLETED PHASE1
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers
NCT01508182 COMPLETED PHASE1
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
NCT00971243 COMPLETED PHASE2
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
NCT00473525 COMPLETED PHASE2