A randomized, double-blind trial comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia

Phase 3

Completed

Conditions: 10012653
diabetes mellitus type 2 and dyslipidaemia

Registration Number: NL-OMON30160

Lead Sponsor: Fournier Laboratories

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

At inclusion (V0):
1. Male or female aged from 18 to 75 years old,
2. With type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications (diet and exercise),
3. With antidiabetic drug status as follows:
• Antidiabetic drug naive patients: who have never been on prior antidiabetic drug treatment,
or,
• Antidiabetic drug free patients: who have not received antidiabetic drug treatment in the last 6 months,
4. Having signed a written informed consent.
At randomization (V1):
5. FPG >= 126 mg/dL dL (>= 7.0 mmol/L) and < 300 mg/dL (< 16.7 mmol/L). Glycemic status of the patients will be confirmed based on two FPG assays, BV0 and BV1,
6. HbA1c >= 6.5% and <= 9.5%,
7. Hypertriglyceridemia with or without hypercholesterolemia, defined by TG >= 150 mg/dL and <= 400 mg/dL (TG >= 1.69 mmol/L and <= 4.52 mmol/L), assayed at BV1.

Exclusion Criteria

Patient with any of the following conditions will not be included in the trial:
1. Known Type 1 diabetes,
2. With LDL-C > 130mg/dL (3.35 mmol/L),
3. In cardiovascular secondary prevention,
4. Body mass index > 40 kg/m2,
5. Women who are not postmenopausal if they are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy), or not using adequate contraceptive precautions,
6. Pregnant or lactating women,
7. Known hypersensitivity to fibrates, metformin, rosiglitazone or any of their components or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen,
8. Known allergy to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions,
9. Having received an investigational drug in the last 30 days before date of inclusion,
10. Unable or unwilling to comply with the protocol and the standard diet and exercise recommendations,
11. Likely to withdraw from the study before its completion.;Concomitant medications:
12. Treated within the last 6 months before randomization with any antidiabetic drug treatment,
13. Treated within the last 2 months before randomization with a lipid-lowering drug (except statins). Patients who were on a statin before inclusion may be included provided the dose does not exceed the maximum daily dose authorized in the study ) and is kept constant throughout the study.
14. Treated within the last 2 months before randomization with cyclosporin A, and any other immunosuppressive agent, with protease inhibitors (indinavir, ritonavir, saquinavir, *), for obesity by medical treatment (orlistat, sibutramine*) and/or surgery (gastroplasty, bypass,*), with rifampin (inducer of CYP2C8)
15. Change within the last 2 months before randomization, and during the course of the study, in the medications that could interfere with the lipid or glycemic profile.;Associated diseases or conditions:
16. Diabetic ketoacidosis, diabetic pre-coma,
17. Current chronic pancreatitis, or identified risk or known history of acute pancreatitis,
18. Known cholelithiasis without cholecystectomy,
19. Significant hepatic disease: AST and/or ALT > 2 times the upper limit of normal (ULN),
20. Musculoskeletal disease with increased creatine phosphokinase (CPK) > 3 times ULN,
21. Renal failure or renal dysfunction defined by a creatinine clearance < 60 mL/min as calculated with the Cockroft-Gault algorithm: creatinine clearance = [(140 - age) x weight (kg) / 7.2 x serum creatinine (mg/L)] for males and [x 0.85] in females,
22. Acute conditions with the potential to alter renal function (such as dehydration, severe infection, shock, intravascular administration of iodinated contrast agents),
23. Acute or chronic disease which may cause tissue hypoxia such as respiratory failure,
24. Known congestive heart failure or past medical history of congestive heart failure (class I to IV),
25. Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level. (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for inclusion),
26. Other uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins,
27. Patients particularly susceptible to hypoglycemic effects, such as debilitated, or malnourished patients, acute alcohol intoxication, exces

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary criteria: HbA1c, TG</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary criteria:<br /><br>Efficacy parameters:<br /><br>• FPG,<br /><br>• TC, HDL-C, LDL-C, Non-HDL-C, LDL particle size, Apo AI, Apo B, Apo CIII,<br /><br>• Body weight.<br /><br><br /><br>Safety parameters:<br /><br>• Adverse events,<br /><br>• Clinical examination including presence of peripheral edema and vital signs,<br /><br>• Hematology: RBC, hemoglobin, hematocrit, platelets, WBC and differential<br /><br>count,<br /><br>• Biochemistry: CPK, AST, ALT, Gamma GT, alkaline phosphatase, total bilirubin,<br /><br>creatinine, uric acid.</p><br>

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