Diabetic Retinopathy Candesartan Trials
Condition: Type 1 Diabetes
MeSH terms: Diabetic Retinopathy
Intervention: candesartan cilexetil
Intervention description: 32 mg once daily oral tablet given over 60 months
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5238.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Insulin-Dependent

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin
             treatment within 1 year of diagnosis of diabetes are included.

          -  Duration of diabetes for > 1 year and < 15 years with stable diabetic therapy within
             last 6 months.

          -  Patients with untreated resting mean sitting SBP < 130 mmHg, mean sitting DBP < 85
             mmHg and with retinal photograph grading level 10/10 (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 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