E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes (T2DM) and dyslipidemia. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |