Diabetic Retinopathy Candesartan Trials

Type 1 Diabetes Clinical Trial

— DIRECT  

Official title:

Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252733
• Other study ID #: D2453C00045
• Secondary ID: DIRECTSH-AHM-004
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: May 9, 2014
• Start date: June 2001
• Est. completion date: April 2008

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5238
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Australia	Research Site	Herston
Australia	Research Site	Perth
Denmark	Research Site	Odense

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Takeda

Countries where clinical trial is conducted

Australia,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.	Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.	From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.	No
Secondary	Rate of Change in Urinary Albumin Excretion Rate (UAER).	An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.	From baseline to end of study, i.e. 5 years.	No

External Links

•   Link
•   CSR-D2453C00045.pdf