Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, en fase IV, para comparar los efectos renales del medio de contraste no iónico isosmolar, iodixanol 320 mg I/ml (VisipaqueTM), con el medio de contraste no iónico de baja osmolaridad, iopamidol 300 mg I/ml, en sujetos con insuficiencia renal y diabetes mellitus sometidos a TC helicoidal multidetector

INTERVENTION: Trade Name: Visipaque 320 mgI/ml Product Name: Visipaque 320 mg I/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Iodixanol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 320 mg I/ml‐ Trade Name: Iopamiro 300 mg I/ml Product Name: Iopamiro Pharmaceutical Form: Solution for injection INN or Proposed INN: Iopamidol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 300 mg I/ml‐ CONDITION: Subjects with a combination of diabetes mellitus (type I or II), and impaired renal function. ; MedDRA version: 7.0 Level: Pt Classification code 10061835 PRIMARY OUTCOME: Main Objective: To evaluate and compare the effects of two different contrast media, iodixanol 320 mg I/mL and iopamidol 300 mg I/mL, on renal function Primary end point(s): The primary endpoint will be the incidence rate of contrast‐induced nephropathy (CIN), defined as an intra‐individual increase in serum creatinine of at least 44.2 µmol/l (0.5 mg/dl) from baseline up to day 3.; ; Secondary Objective: To evaluate and compare the safety profile of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL; To evaluate and compare the efficacy of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL; INCLUSION CRITERIA: 1.) The subject is at least 18 years old. 2.) The subject has diabetes mellitus (type I or II), treated with insulin or oral antidiabetic agents for at least 1 year. 3.) The subject has a pre‐study serum creatinine = 1.7 mg/dl (150 µmol/l) if a man, or = 1.5 mg/dl (133 µmol/l) if a woman, or an estimated pre‐study glomerular filtration rate (eGFR) = 50 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation.* The pre‐study serum creatinine value must not be older than 3 months and any acute causes of impaired renal function have to be ruled out. * the four‐component MDRD equation provides estimates of GFR standardised for body surface, based on the variables serum creatinine concentration (SCr), age, race, and sex: eGFR (mL/min/1.73m2) = 186 x SCr‐1.154 x age‐0.203 (x 0.742 if female) (x 1.210 if black) Pre‐study serum creatinine has to be expressed in milligrams per decilitre, age in years. 4.) The subject is