Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.


Options:
A: 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.
B: Inclusion Criteria:

* Non-obese patients (BMI \< 27 kg/m2)
* Type 2 diabetes
* Age 40 years or older
* HbA1c = 6.5% or higher at baseline.

Exclusion Criteria:

* No known contraindications for either of the study-drugs (known allergy to the study-drugs; heart-, liver- or kidney-failure)
* Pregnancy
* Other serious physical or mental illnesses with a life-shortening prognosis.
* Drug or alcohol abuse.
* Weight-loss of more than 5 kg during the last 6 month prior to enrollment.
C: Inclusion Criteria:

* Has HbA1c \>7.0% and \<=10.5%
* Has a body mass index (BMI) \>=25 kg/m2 and \<=45 kg/m2
* Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
* If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria:

* Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
* Has received any investigational drug within 1 month of screening
D: Inclusion Criteria:

* Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
* C-peptide \>0.6 ng/ml (\>0.20 nmol/L).
* HbA1c ≥7.5 to ≤11% at Visit 1
* Treatment with stable, once or twice daily doses (maximum dose of \< 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
* Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
* Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for participation in the study

* Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
* Pregnant or lactating women
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Current diagnosis of congestive heart failure (NYHA III or IV).
* Myocardial infarction (MI) within the past 6 months
* Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply

Answer: D