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Diabetic Retinopathy Candesartan Trials (DIRECT)

This study has been completed.
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252733
First received: November 10, 2005
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Drug: candesartan cilexetil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to the First Occurrence of an Event (2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (EDTRS) 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. [ Time Frame: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year. ] [ Designated as safety issue: No ]
    A generalized log-rank test was used to test difference between treatments


Secondary Outcome Measures:
  • Rate of Change in Urinary Albumin Excretion Rate (UAER). [ Time Frame: From baseline to end of study, i.e. 5 years. ] [ Designated as safety issue: No ]
    An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.


Enrollment: 5238
Study Start Date: June 2001
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Placebo
Experimental: 2
candesartan cilexetil
 Drug: candesartan cilexetil
32 mg once daily oral tablet given over 60 months
Other Name: ATACAND

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252733

Locations
Australia
Research Site
Herston, Australia
Research Site
Perth, Australia
Denmark
Research Site
Odense, Denmark
Sponsors and Collaborators
AstraZeneca
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: AstraZeneca Atacand Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252733     History of Changes
Other Study ID Numbers: D2453C00045, DIRECT, SH-AHM-0045
Study First Received: November 10, 2005
Results First Received: March 31, 2009
Last Updated: March 19, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:
Diabetes Mellitus, Insulin-Dependent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Candesartan cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013