Patients with type 2 diabetes mellitus
Conditions
Interventions
Product Name: 80mg fenofibrate
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: fenofibrate
CAS Number: 49562-28-9
Current Sponsor code: NA
Other descriptive name: NA
Con
Sponsors
FOURNIER Laboratories Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males or females aged from 40 to 75 years at inclusion; - T2DM as defined by ADA criteria (fasting glucose > 7.0 mmol/L, e.g. 126 mg/dL; or OGTT glucose at 120 minutes > 11.1 mmol/L, e.g. 200 mg/dL. - Inclusion criteria for inclusion at visit V1: o For patients under oral antidiabetic treatment at inclusion which will be stopped during the washout period: fasting glucose = 6.0 mmol/L and/or OGTT glucose at 120 minutes = 10 mmol/L, and/or HbA1c = 6% and 25 kg/m² and = 40 kg/m² - Having signed a written informed consent at inclusion. 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: - Unable or unwilling to comply with the protocol; - Ongoing or past treatment with cyclosporin A or protease inhibitors (indinavir, ritonavir, saquinavir, …); - Ongoing treatment with statins (atorvastatin, simvastatin, pravastatin, rosuvastatin…) at the date of V1 - LDL-C = 190 mg/dL (4.9 mmol/L) if no risk factor, LDL-C = 160 mg/dL (4.1 mmol/L) if a single risk factor exists or LDL-C = 130 mg/dL (3.4 mmol/L) in case of two or more risk factors; - Proliferative retinopathy or maculopathy requiring laser therapy; - Ongoing treatment with thiazolinediones (rosiglitazone, pioglitazone…) at the date of V1 - Ongoing treatment with insulin at the date of V1 - Reporting a change within the last 4 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., betablockers, diuretics, oral corticosteroids, thyroid hormones, retinoids, hormone replacement therapies) - Patients affected with one of the following diseases or conditions: · Chronic respiratory insufficiency, patient with medical device for sleep apnea; · Chronic pancreatitis, or identified risk or known history of acute pancreatitis; · Hepatic insufficiency, acute alcohol intoxication, alcoholism · Renal insufficiency with calculated creatinine clearance = 60 mL/min · Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), or shock; · Recent cerebrovascular stroke (within 3 months prior to randomization) or any other life-threatening vascular complication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study by 2-step hyperinsulinemic euglycemic clamp (HEC), the effects of metformin, fenofibrate and their combination on: 1°) Endogenous Glucose Production (EGP), and 2°) Glucose Disposal Rate (GDR). HEC will be performed according to the standardized procedure used for the EGIR-RISC Project (European Group for the Study of Insulin Resistance - Relationship between Insulin Sensitivity and Cardiovascular disease).;Secondary Objective: To investigate the effects of metformin, fenofibrate and their combination on: - Gluconeogenesis (GNG) - Glycogenolysis (GGL) - Skeletal muscle and liver fat content measured by magnetic resonance spectroscopy (MRS) - Abdominal fat content measured by magnetic resonance imaging (MRI) - Body energy expenditure and respiratory quotient measured by indirect calorimetry - Lipids, lipoproteins and carbohydrate metabolism and other biochemical parameters - Other safety test parameters.;Primary end point(s): Main primary criteria, percent change of low-dose insulin-suppressed EGP as investigated by HEC (µmol/kgffm/min; where kgffm is the fat-free mass in kg). Other primary criteria, percent change of: - Basal EGP (µmol/kgffm/min), - High-dose insulin-suppressed EGP (µmol/kgffm/min), - Basal GDR (same as basal EGP; µmol/kgffm/min), - Low-dose insulin-stimulated GDR (µmol/kgffm/min), - High-dose insulin-stimulated GDR (µmol/kgffm/min). | — |
Countries
Finland
Outcome results
None listed