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:

* Prospective participant is a returning patient with type 2 diabetes;
* Prospective participant expressed an intention to fast during Ramadan;
* Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.

Exclusion Criteria:

* Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
* Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
* Prospective participant has received niacin or corticosteroids within one month; and,
* Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.
B: Inclusion Criteria:

* Type 2 diabetes (Group 4 -low-risk group as defined by International Diabetes Federation ) - low-risk group is defined as a well-controlled diabetic patient treated with lifestyle modification and oral anti-diabetic medications
* The patient was diagnosed with type 2 diabetes before the previous Ramadan. They also had fasted during previous year of Ramadan (2020) and are planning to fast during the coming Ramadan (2021)

Exclusion Criteria:

* Patients with poor glycemic control; HbA1c of 8% or more
* Patients with other serious complications
* Pregnant, maternal, breastfeeding or pregnant women
* Patients with severe renal dysfunction (serum creatinine level of 1.5 mg/dl or higher)
* Patients who advised not to fast by doctor
* Patients participating in other clinical trials
* Patients with contraindications to D-allulose
C: Inclusion Criteria:

* All Muslim patients over 21 years of age with Type 2 diabetes who plan to fast for at least 10 days during the month of Ramadan

Exclusion Criteria:

* Patients with history of recurrent hypoglycemia
* Patients who are pregnant
* Patients with eGFR\<30ml/min 3 months prior to Ramadan
* Patients with HbA1c \> 9.5%
* Patients with DM-related admission 1 month prior to Ramadan
* Patients on active short-term corticosteroid treatment
* Patients who are unable to complete the questionnaires
D: 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"

Answer: D