Type 1 Diabetes Clinical Trial
Official title:
DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
The primary objective is to determine whether candesartan, compared to placebo reduces the
progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic
patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces
the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic
retinopathy (PDR) and beneficially influences the rate of change in urinary albumin
excretion rate (UAER).
This study is part of the DIRECT Programme also including a primary prevention study of
diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes.
The primary objective for all three pooled studies is to determine whether candesartan,
compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic
patients.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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