DIabetic Retinopathy Candesartan Trials (DIRECT)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes mellitus type 2
Eligibility Criteria
Inclusion Criteria: Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter. Duration of diabetes for > 1 year and < 20 years with stable diabetic therapy within last 6 months. Patients with untreated resting mean sitting SBP < 130 mmHg and mean sitting DBP < 85 or treated resting mean SBP < 160 mmHg and mean sitting DBP < 90 mmHg with retinal photograph grading level >20/10 up to < 47/47 (on ETDRS severity scale). Exclusion Criteria: Patients with the following conditions are excluded from participation in the study: Cataract or media opacity of a degree which precludes taking gradable retinal photographs Angle closure glaucoma, which precludes pharmacological dilatation of the pupil History of or presence of proliferative retinopathy History or presence of clinical significant macular oedema (CSME) History or evidence of photocoagulation of the retina Other retinal conditions which may mask assessment, eg, retinal vein occlusion Positive micral dipstick test Presence of secondary diabetes Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception Need of treatment with ACE-inhibitor Haemodynamically significant aortic or mitral valve stenosis Known renal artery stenosis or kidney transplantation Hypersensitivity to study drug Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
candesartan
placebo
candesartan cilexetil 32 mg once daily
control