Phase 3
N=1,905
DIabetic Retinopathy Candesartan Trials.
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00252720 ↗Enrolled (actual)
1,905
Serious AEs
17.6%
Results posted
Jun 2014
Primary outcome: Primary: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale — 127; 124 Participants — p=0.8487
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- candesartan (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale |
127; 124 | 0.8487 |
| SECONDARY Number of Participants With a Regression of Diabetic Retinopathy. |
140; 139 | — |
| SECONDARY Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). |
110; 107 | — |
| SECONDARY Rate of Change in Urinary Albumin Excretion Rate (UAER). |
0.569; 0.642 | — |
Summary
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).
This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in 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
- Male or female aged 18 - 55 years with 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 20/10 up to < 47/47 (on ETDRS severity scale).
Exclusion Criteria
- Patients with the following conditions are excluded from participation on 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 or presence of proliferative 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 (NCT00252720). 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.