Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Brief Summary: To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.


Options:
A: Inclusion Criteria:

* Males and females, age 50-75 years
* Type 2 diabetes of at least 2 years duration
* BMI 20-45 Kg/m2
* Stable treatment for the last two months with metformin in monotherapy (at least 2 gr/die)
* HbA1c \>=7.0% and \<=9.0%

Exclusion Criteria:

* Type 1 diabetes
* Previous treatment with thiazolidinediones in the last six months
* Contraindication/intolerance to metformin or SUs or TZDs
* Documented coronary or cerebrovascular events in the previous 3 months
* Serum creatinine \> 1.5 mg/dl
* History of congestive heart failure, NYHA I or higher
* Chronic use of glucocorticoids
* Ischemic ulcer or gangrene
* Liver cirrhosis or severe hepatic dysfunction (ALT increase of 2.5 times the upper normal limit)
* Pregnancy or breast feeding
* Cancer, substance abuse, or any health problem that may interfere with the compliance to the study protocol or limit life expectancy
B: Inclusion criteria:

* .Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
* glycosylated haemoglobin (HbA1c) at Visit 1: \>=7.0 to =\<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
C: Inclusion Criteria:

* Confirmed Type 2 Diabetes diagnosis
* Plan to fast during Ramadan
* Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
* Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
* Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
* Inability to comply with the study procedures or medications.

"Other protocol-defined inclusion/exclusion criteria may apply"
D: Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
* Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* or a severe hypoglycemic episode within 6 months before screening

Answer: C