Official Title: “Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: candesartan cilexetil
  • 32 mg once daily oral tablet given over 60 months

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Placebo
• Experimental: 2
  • candesartan cilexetil

Primary Measures

• Incidence of diabetic retinopathy is a change from baseline to any retinal photograph taken after the randomization visit by at least 2 steps from 10/10 in the ETDRS severity scale.
  • Time Frame: assessed after 60 months of treatment
    Safety Issue?: No

Secondary Measures

• The rate of change in mean urinary albumin excretion rate (UAER)
  • Time Frame: from baseline to the end of the study (60 months)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Atacand Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00252733

Study ID Number: D2453C00045

ClinicalTrials.gov Identifier: NCT00252733

Health Authority: Denmark: Danish Medicines Agency