Assessment of insulin sensitivity in type 2 diabetics treated with metformin, fenofibrate and their combination - NA

FOURNIER Laboratories Ireland Ltd0 sites100 target enrollmentMarch 21, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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 \<9% at inclusion or during the last four months before inclusion,
•o For patients which are not under oral antidiabetic treatment at inclusion, criteria are the same as randomization criteria: fasting glucose \= 7\.0 mmol/L, and/or OGTT glucose at 120 minutes \= 11\.1 mmol/L and/or HbA1c \= 7% and \<10% at inclusion or during the last four months before inclusion
•\- Plus at least one of the following biochemical abnormalities:
•o Triglycerides (TG) \= 150 mg/dL (\= 1\.69 mmol/L); and/or
•o HDL\-C \= 40 mg/dL (\= 1\.03 mmol/L) for male patients or HDL\-C \= 50 mg/dL (\= 1\.29 mmol/L) for female patients;
•\- BMI (body mass index) \> 25 kg/m² and \= 40 kg/m²
•\- Having signed a written informed consent at inclusion.

•\- 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;