Conditions: Type 1 Diabetes
Keywords: Diabetes Mellitus, Insulin-Dependent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5238
Healthy volunteers: no

Brief summary:
The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and 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.

Detailed description:

Arms:
arm 1: Placebo arm 2: candesartan cilexetil

Interventions: intervention 1: candesartan cilexetil
Intervention descriptions: intervention 1: 32 mg once daily oral tablet given over 60 months

Protocol document: