The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

NCT ID: NCT00400231

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-03-31

Brief Summary

Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.

Conditions

Metabolic Syndrome x

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

1

Metformin

Group Type: ACTIVE_COMPARATOR

Study Drug: Metformin

Intervention Type: DRUG

2000mg/day

2

Fenofibrate

Group Type: ACTIVE_COMPARATOR

Study Drug: fenofibrate

Intervention Type: DRUG

145mg/day of fenofibrate

3

Fenofibrate and Metformin

Group Type: ACTIVE_COMPARATOR

Study drugs: Metformin and fenofibrate

Intervention Type: DRUG

145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.

4

Group Type: PLACEBO_COMPARATOR

Metformin and Fenofibrate placebo

Intervention Type: DRUG

placebo metformin and fenofibrate

Interventions

Study drugs: Metformin and fenofibrate

145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.

Intervention Type: DRUG

Study Drug: Metformin

2000mg/day

Intervention Type: DRUG

Study Drug: fenofibrate

145mg/day of fenofibrate

Intervention Type: DRUG

Metformin and Fenofibrate placebo

placebo metformin and fenofibrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects between the ages of 18 and 75 with both of the following risk factors:

1. Fasting triglycerides >= 150 mg/dl (but less than 800 mg/dl)

2. Glucose of 140 to 199 mg/dl, 2 hours after a 75 gm oral glucose load, a fasting HOMA level in the upper quartile (> 2.68), or a plasma triglyceride to high density lipoprotein cholesterol concentration > 3.0

And at least one of the following three:

1. Central obesity (waist size > 40 inches in men or >35 inches in women)

2. A systolic blood Pressure of >130 mmHg and/or a diastolic blood pressure of >85 mmHg and/or taking an antihypertensive medication.

3. HDL < 40 mg/dl for men or < 50 mg/dl for women

Exclusion Criteria

1. Blood pressure > 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained)

2. Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control.

3. Chronic renal insufficiency (serum creatinine >1.5 mg/dl in men and > 1.4 mg/dl in women

4. Any active liver disease or abnormal LFTs (>2x upper limit normal)(12)

5. Active infection, malignancy or chronic inflammatory disorder

6. Concomitant use of niacin, a bile acid sequestrant, or ezetimibe. If it is deemed safe by the patient's primary physician and by the principal investigator, patients may be screened for enrollment upon stopping these medications for at least 2 weeks.

7. Subjects on statins will need to be on less than maximal dose (e.g. < 80 mg per day for simvastatin or atorvastatin). Subjects will also need to have been on a stable dose of statin therapy for at least 1 month prior to enrollment and continue their currently prescribed statin at the same dose throughout the study. If it is deemed safe by the patient's primary physician and by the principal investigator, patients on maximal statin therapy (usually 80 mg/day) may reduce their dose of statin therapy to a sub maximal dose (usually 40 mg/day) for 4 weeks prior to screening for enrollment.

8. History of lactic acidosis(12)

9. Expected need for use of intravenous radiographic contrast during the study

10. More than moderate alcohol use (> 14 drinks per week)

11. Moderate to severe left ventricular dysfunction (ejection fraction <45%)

12. Decompensated heart failure or decompensated lung disease that has resulted in hypoxia or reduced peripheral perfusion within the past year regardless of left ventricular ejection fraction (thus patients with underlying heart disease, coronary artery disease, mild left ventricular dysfunction (ejection fraction > 45%), or lung disease that has been stable for at least one year will be eligible to participate)

13. Creatinine kinase (CK) levels ≥ 2.5 ULN or history of statin-induced myopathy. Patients with a CK level more than 2.5 times the upper limit of normal may undergo repeat testing up to two more times before being excluded (since vigorous physical activity can often elevate CK levels, and this would not increase the risk of myopathy).

14. Participation in an investigational drug study within 6 weeks prior to the screening visit

15. Surgery within the previous 30 days

16. Concomitant use of ketoconazole, itraconazole, cyclosporin A, erythromycin, or Clarithromycin.

17. Hemoglobin < 10 mg/dl, active use of coumadin, history of bleeding disorder, or abnormal clotting time (protime >14.6 seconds and aPTT > 37.0)

18. Septic shock

19. Acute coronary syndrome or stroke within 3 months prior to study

20. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick F. Samaha, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

800860

Identifier Type: -

Identifier Source: org_study_id