Patients with type 2 diabetes (T2DM) and dyslipidemia. MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: fenofibrate/metformin fixed dose combination
Product Code: LF23-0121
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: fenofibrate
CAS Number: 49562-28-9
Current Sponsor code:
Sponsors
FOURNIER Laboratories Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged from 20 to 80 years (at inclusion visit) 2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycemic agent 3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin 4. And having signed a written informed consent 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, uncontrolled type 2 diabetes [HbA1c = 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)] 2. TG > 500 mg/dL (5.65 mmol/L) on the last performed blood sample (within the last 3 months) 3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (>1 year since their last menstrual period) 4. Pregnant or lactating women 5. Known hypersensitivity to fibrates or metformin 6. Having received an investigational drug in the last 30 days before date of inclusion 7. Unable or unwilling to comply with the protocol 8. Likely to withdraw from the study before its completion Concomitant medications: 9. Other than 1000 mg bid metformin regimen 10. Treated with Cyclosporin A 11. Treated with oral anticoagulants 12. Treated with protease inhibitors (indinavir, ritonavir, saquinavir, …) Associated diseases or conditions: 13. Diabetic ketoacidosis, diabetic pre-coma 14. Current chronic pancreatitis, or identified risk or known history of acute pancreatitis 15. History of cholelithiasis with no cholecystectomy 16. Significant hepatic disease: AST and/or ALT > 2 times the upper normal limit (UNL) 17. History of musculoskeletal disease: increased creatine phosphokinase (CK) > 3 times UNL 18. Renal failure or renal dysfunction defined by creatinine clearance = 60 mL/min as calculated with the Cockcroft-Gault formula (for male, creatinine clearance (mL/min) = [(140 - age) x weight] / (serum creatinine x 72); for female, creatinine clearance (mL/min) = [(140 - age) x weight x 0.85] / (serum creatinine x 72); where age is in years, weight is in kilograms and serum creatinine is in mg/dL) 19. Acute conditions with the potential to alter renal function (such as dehydration, severe infection, shock, intravascular administration of iodinated contrast agents) 20. Acute or chronic disease which may cause tissue hypoxia (such as cardiac or respiratory failure, recent myocardial infarction within 3 months prior to randomisation, shock) 21. Patients particularly susceptible to hypoglycaemic effects, such as debilitated, or malnourished patients, acute alcohol intoxication, alcoholism defined as above 50 units per week (1 unit = 360 mL/12 oz beer; 120-150 mL/4-5 oz wine; 45 mL/1.5 oz spirits) 22. Any other severe pathology such as cancer, mental illness, etc…, which in the opinion of the investigator might pose a risk to the patient or confound the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the acceptability of a 4-week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia. ;Secondary Objective: NA;Primary end point(s): All items of the questionnaires quoted by a Visual Numeric Rating Scale (2 items at V1 and 4 items at V2) will be described (continuous summary statistics and frequency table). The mean of the 4 items at V2 will be described. As the 3 highest scores on a scale from 0 to 10 are considered as reflecting high degrees of satisfaction, bar charts will be plotted showing the distribution of patients with scores < 8 or = 8 by visit for each items. No inferential statistics will be done. | — |
Countries
France
Outcome results
None listed