Patients with type 2 diabetes mellitus and dyslipidemia not appropriately controlled with a statin
Conditions
Interventions
Product Name: fenofibrate/metformin fixed combination
Product Code: LF23-0121
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: fenofibrate/metformin
CAS Number: NA
Current Sponsor code: LF
Sponsors
FOURNIER Laboratories Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At inclusion (V0): 1. Male or female aged from 18 to 75 years, 2. With T2DM treated with stable dose of metformin (500 mg bid, 850 mg bid, 850 mg tid) for a minimum of 3 months, either alone or in combination with another oral hypoglycemic agent (sulfonylurea, meglitinide analogue, or a-glucosidase inhibitor), 3. With dyslipidemia not appropriately controlled with a statin treatment and lifestyle recommendations, based on the clinical values of TG and LDL-C in patient medical files (not older than 3 months), 4. Treated within the last 3 months with a statin treatment at a dose not exceeding the maximum daily dose authorized in the study i.e. atorvastatin 20 mg - fluvastatin, lovastatin, pravastatin and simvastatin 40 mg - rosuvastatin 10 mg. The statin treatment has to be kept constant throughout the study, 5. Having signed a written informed consent. At randomization (V1) the following parameters must comply with: 6. 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, 7. LDL-C = 130mg/dL (3.35 mmol/L), 8. HbA1c = 8.5% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known Type 1 diabetes, 2. In cardiovascular secondary prevention, 3. Body mass index > 40 kg/m2, 4. Women who are not postmenopausal if they are not surgically sterilized, or not using adequate contraceptive precautions, 5. Pregnant or lactating women, 6. Known hypersensitivity to fibrates, metformin, or any of their components or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen, 7. Known allergy to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions, 8. Having received an investigational drug in the last 30 days before date of inclusion, 9. Unable or unwilling to comply with the protocol, 10. Likely to withdraw from the study before its completion. Concomitant medications: 11. Treated within the last 3 months before inclusion with a lipid-lowering drug other than statins, 12. Treated within the last 3 months before inclusion with thiazolidinedione, insulin, fixed-dose formulations of 2 oral antihyperglycemic drugs including metformin 13. Change within the last month before inclusion, and during the course of the study, in the medications that could interfere with the lipid or glycemic profile, 14. Treated within the last month before inclusion with cyclosporin A, and any other immunosuppressive agent, with protease inhibitors, for obesity by medical treatment and/or surgery. Associated diseases or conditions: 15. Diabetic ketoacidosis, diabetic pre-coma, 16. Current chronic pancreatitis, or identified risk or known history of acute pancreatitis, 17. Known cholelithiasis without cholecystectomy, 18. Significant hepatic disease: AST and/or ALT > 2 times the upper limit of normal (ULN), 19. Musculoskeletal disease with increased creatine phosphokinase (CPK) > 3 times ULN, 20. 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, 21. Acute conditions with the potential to alter renal function, 22. Cardiac or respiratory failure or any acute or chronic disease which may cause tissue hypoxia, 23. 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), 24. Other uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, 25. Patients particularly susceptible to hypoglycemic effects, such as debilitated, or malnourished patients, acute alcohol intoxication, excessive alcohol intake, 26. Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomization capable of modifying the intestinal absorption of the drugs, 27. Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation. In addition in patients aged under 35 years the following exclusion criteria will apply 28. Body mass index < 25 kg/m2, 29. Ever been treated by Insulin, 30. Family history of type 1 diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate in patients with type 2 diabetes mellitus (T2DM) and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination (FC) of fenofibrate and metformin vs metformin alone on: Triglycerides (TG) · and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C.;Secondary Objective: To assess the efficacy of fenofibrate and metformin FC compared to metformin alone on TG and HDL-C, in the following subgroups of interest: · Gender: male / female, · TG level at baseline: 150 mg/dL = TG < 300 mg/dL (1.69 mmol/L = TG < 3.38 mmol/L) and 300 mg/dL = TG = 400 mg/dL (3.38 mmol/L = TG = 4.52 mmol/L), · Statin dose: high / low. To assess the efficacy of fenofibrate and metformin FC compared to metformin alone on: · HbA1c, · FPG, · Fructosamine, · TC, · LDL-C (measured), · VLDL-C (calculated), · Non HDL-C (calculated), · LDL particle size, · Apo AI, · Apo B, · Apo CIII, · Body weight. To assess the safety of fenofibrate and metformin FC and metformin alone based on several parameters. ;Primary end point(s): Percentage change in TG and in HDL-C from baseline to endpoint | — |
Countries
Czech Republic, Germany, Hungary, Lithuania
Outcome results
None listed