Phase 3
N=1,421
Diabetic Retinopathy Candesartan Trials
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00252733 ↗Enrolled (actual)
1,421
Serious AEs
15.1%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. — 178; 217 Participants — p=0.0508
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- candesartan cilexetil (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. |
178; 217 | 0.0508 |
| SECONDARY Rate of Change in Urinary Albumin Excretion Rate (UAER). |
0.510; 0.543 | — |
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
Data sourced from ClinicalTrials.gov (NCT00252733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.