Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)
Brief Summary: This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.


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:

1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
2. Age 55 years or older at entry
3. Ability to provide informed consent
4. A substantially elevated risk of cardiovascular disease, indicated by:

   * A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or
   * A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio \>300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or
   * A first diagnosis of type 2 diabetes made 10 or more years prior to entry or
   * Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol \<1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or
   * Age 65 years or over

Exclusion Criteria:

1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
5. A definite indication for long-term full-dose or bed-time insulin therapy
6. Participation in a trial within the month prior to the Registration Visit or current participation in another trial

Other potential reasons for ineligibility include:

* High probability of non-adherence to study treatment or follow-up
* Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks)
* Life threatening non-vascular disease other than diabetes and its complications
* Moderate or severe dementia
* Major disability that is likely to prevent regular attendance at study clinics

Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies.
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: A