Conditions: Type 1 Diabetes
Keywords: Diabetes mellitus type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1850
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: candesartan cilexetil 32 mg once daily arm 2: control

Interventions: intervention 1: candesartan
Intervention descriptions: intervention 1: 32 mg oral tablet

Protocol document: