A Phase 3 interventional study of candesartan in Type 2 Diabetes, sponsored by AstraZeneca. Completed. Open to participants aged 37 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 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 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 1 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.
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 4,717 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
candesartan cilexetil 32 mg once daily
Drug: candesartan
control
32 mg oral tablet
Also known as: ATACAND
Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.
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.
Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.
3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).
Time frame: From baseline to end of study, i.e. 5 years.
Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).
Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.
Time frame: From baseline to end of study, i.e. 5 years.
Rate of Change in Urinary Albumin Excretion Rate (UAER).
An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.
Time frame: From Baseline to end of study, i.e. 5 years.
First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. A total of 4717 patients enrolled into the programme of whom 1905 patients proceeded to randomization into Study 47.
| Milestone | Candesartan | Placebo |
|---|---|---|
| Started | 951 | 954 |
| Completed | 807 | 800 |
| Not completed | 144 | 154 |
| Withdrew: Withdrawal by subject | 83 | 91 |
| Withdrew: Death | 36 | 34 |
| Withdrew: Mostly lost to follow up | 8 | 13 |
| Withdrew: Patient moving | 17 | 16 |
3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.
| Participants | Candesartan | Placebo |
|---|---|---|
| Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | 161 ± 0.045 | 182 ± 0.052 |
3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).
| Participants | Candesartan | Placebo |
|---|---|---|
| Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | 180 ± 0.054 | 136 ± 0.040 |
Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.
| Participants | Candesartan | Placebo |
|---|---|---|
| Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | 192 ± 0.06 | 193 ± 0.06 |
An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.
| log (µg/min)/1000 year | Candesartan | Placebo |
|---|---|---|
| Rate of Change in Urinary Albumin Excretion Rate (UAER). | 656 (605 to 708) | 718 (666 to 770) |
Collected over During treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Candesartan | — | 301/949 (31.7%) | 50/949 (5.3%) |
| Placebo | — | 267/953 (28%) | 18/953 (1.9%) |
| Event | Candesartan | Placebo |
|---|---|---|
| Myocardial InfarctionCardiac disorders | 19/949 | 18/953 |
| Angina PectorisCardiac disorders | 17/949 | 10/953 |
| Acute Myocardial InfarctionCardiac disorders | 7/949 | 14/953 |
| CataractEye disorders | 11/949 | 6/953 |
| Chest PainGeneral disorders | 11/949 | 6/953 |
| Cerebrovascular AccidentNervous system disorders | 10/949 | 9/953 |
| Angina UnstableCardiac disorders | 7/949 | 10/953 |
| Coronary Artery DiseaseCardiac disorders | 3/949 | 10/953 |
| Atrial FibrillationCardiac disorders | 9/949 | 3/953 |
| HyperglycaemiaMetabolism and nutrition disorders | 9/949 | 7/953 |
| Event | Candesartan | Placebo |
|---|---|---|
| HypotensionVascular disorders | 50/949 | 18/953 |
| Age, Categorical(Participants) | Candesartan | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 809 | 808 | 1617 |
| >=65 years | 142 | 146 | 288 |
| Age, Continuous(years) | Candesartan | Placebo | Total |
|---|---|---|---|
| Mean | 56.9 ± 7.6 | 56.8 ± 7.9 | 56.8 ± 7.8 |
| Sex: Female, Male(Participants) | Candesartan | Placebo | Total |
|---|---|---|---|
| Female | 485 | 472 | 957 |
| Male | 466 | 482 | 948 |
| Region of Enrollment(participants) | Candesartan | Placebo | Total |
|---|---|---|---|
| Russian Federation | 162 | 165 | 327 |
| Europe | 419 | 438 | 857 |
| Israel | 188 | 173 | 361 |
| South Africa | 182 | 178 | 360 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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