Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: 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.


Options:
A: 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
B: Inclusion Criteria:

* Type 1 diabetes
* Treated with insulin for at least 12 months
* Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or
* Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

Exclusion Criteria:

* Previous birth of child with a major congenital malformation
* More than 2 previous multiple miscarriages or stillbirths
* Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement
* Subjects being treated for infertility
* Proliferative retinopathy or maculopathy requiring acute treatment
* Drug or alcohol abuse
* Impaired renal, hepatic or cardiac function
C: Inclusion Criteria:

* Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
* Duration of diabetes for \> 1 year and \< 20 years with stable diabetic therapy within last 6 months.
* Patients with untreated resting mean sitting SBP \< 130 mmHg and mean sitting DBP \< 85 or treated resting mean SBP \< 160 mmHg and mean sitting DBP \< 90 mmHg with retinal photograph grading level \>20/10 up to \< 47/47 (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 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
D: 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 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 \> 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

Answer: C