Please select the eligibility criteria that correspond to the clinical trial below.
Title: CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus
Brief Summary: The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.


Options:
A: Inclusion Criteria:

* Adults
* Impaired glucose tolerance
* Age dependent risk factors

Exclusion Criteria:

* Frank diabetes

For detailed information, call contact person.
B: Inclusion Criteria:

* impaired glucose tolerance (FPG \< 7 mmol/L or 126 mg/dL AND 2 hr PG \>= 7.8 mmol/L and \< 11.1 mmol/L (140 mg/dL and \< 200 mg/dL)or,
* isolated impaired fasting glucose (FPG \>= 6.1 mmol/L and \< 7 mmol/L (FPG \>= 95 mg/dL and \< 126 mg/dL) AND 2 hr PG \< 7.8 mmol/L (140 mg/dL).

Exclusion Criteria:

* current use of an ACE-inhibitor (ACE-I) or thiazolidinedione(TZD)
* known hypersensitivity to ACE-I
* prior use of anti-diabetic medications (with the exception of during pregnancy)
* use of systemic glucocorticoids or niacin
* congestive heart failure or EF \< 40%
* existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
* diabetes
* renal or hepatic disease
* major illness
* use of another experimental drug
* pregnant or unwilling to use reliable contraception
* major psychiatric disorder
* diseases that affect glucose tolerance
* unwillingness to be randomized or sign informed consent
* known uncontrolled substance abuse
* inability to communicate with research staff
C: Inclusion Criteria:

* clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
* albumin-to-creatinine ratio \>= 300 mg/g creatinine in first morning urinalysis
* serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria:

* type 1 diabetes
* non-diabetic nephropathy
* history of myocardial infarction
* history of cardiac bypass grafting within 3 months
* history of percutaneous coronary intervention (PCI) within 6 months
* history of carotid artery or peripheral artery revascularization within 6 months
* stroke or transient ischemic attack (TIA) within 1 year
* unstable angina pectoris
* heart failure of NYHA functional classes III or IV
* rapid progression of kidney disease within 3 months
* severe orthostatic hypotension
* serum potassium level =\<3.5 mEq(mmol)/L or =\>5.5 mEq(mmol)L
* history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
* poor glycemic control: HbA1c level =\>11%
* history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
D: Inclusion Criteria:

* Women aged \> 60 years and men \> 55 years
* At least one additional CV risk factor including:
* Waist/hip ratio ≥ 0.90 in men and ≥ 0.85 in women;
* History of current or recent smoking (regular tobacco use within 5 years)
* Low HDL cholesterol
* Dysglycemia
* Renal dysfunction
* Family history of premature CHD in first degree relatives

Exclusion Criteria:

* Documented clinically manifest atherothrombotic CVD
* Clear indication or contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy
* Symptomatic hypotension
* Chronic liver disease
* Inflammatory muscle disease
* Renal impairment
* Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
* Concurrent treatment with a statin, fibrate, angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
* Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
* Concurrent use of an experimental pharmacological agent

Answer: C