Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
Brief Summary: This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.


Options:
A: Inclusion Criteria

1. Able, in the opinion of the Investigator, and willing to give informed consent
2. Age ≥ 25 years old
3. Established T2DM (≥ 3 months) on stable dose monotherapy (metformin only for ≥ 8 weeks prior to enrolment) OR stable dose dual therapy (metformin plus either repaglinide, a sulphonylurea or pioglitazone or DPP-4 inhibitor for ≥ 8 weeks prior to enrolment)
4. HbA1c between 6.6 - 11% (49mmol/mol - 97mmol/mol) at the screening visit
5. Individuals intending to fast during the holy month of Ramadan

Exclusion Criteria

1. Unable, in the opinion of the Investigator, and unwilling to provide informed consent
2. Aged \< 25 years old
3. Established T2DM (≤ 3 months) on medication for fewer than 8 weeks prior to enrolment
4. HbA1c ≤6.5 and ≥11.1%
5. Individuals not intending to fast during the holy month of Ramadan
6. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. The latter includes avoiding sex, hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study, or not heterosexually active. Furthermore, subjects who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study. Women of childbearing potential must have a negative urine pregnancy test at baseline.
7. Suffer from terminal illness
8. Have renal disease that requires immunosuppressive therapy, dialysis or transplant
9. Have nephrotic syndrome or inflammatory renal disease
10. Have an estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m2 at screening
11. Have serum creatinine levels \>132.6μmol/L for men or \>123.8μmol/L for women
12. Impaired liver function (ALAT ≥ 2.5 times upper limit of normal)
13. Known Hepatitis B antigen or Hepatitis C antibody positive
14. Clinically significant active cardiovascular disease (including history of myocardial infarction, unstable angina, previous revascularization procedure or cerebrovascular accident) within the past 6 months before screening
15. Have uncontrolled hypertension (defined as systolic blood pressure ≥180mm/Hg and diastolic ≥100mm/Hg in the supine position after \>5minutes rest with confirmed compliance to antihypertensive medication)
16. Heart failure (NYHA class III and IV) at the discretion of the investigator
17. Previous history of recurrent major hypoglycaemia as judged by the study clinician
18. Known or suspected allergy to the study product
19. Receipt of any investigational drug within four weeks prior to this study
20. Has had previous treatment with a GLP-1 receptor agonist, insulin, or another SGLT2 inhibitor within 12 weeks of screening
21. Have severe and enduring mental health problems
22. Are not primarily responsible for their own care
23. Are receiving insulin therapy
24. Type 1 diabetes
25. Any contraindication to sulphonylureas, repaglinide, pioglitazone and/or DPP-4 inhibitors
26. Have severe irritable bowel disorder
27. Have hereditary glucose-galactose malabsorption
28. Have primary renal glycosuria
29. Patients who have participated in another study of an investigational medicinal product in the last 3 months
30. High risk of bone fracture (undiagnosed osteoporosis) as determined by the WHO FRAX tool
31. Evidence of excessive and compulsive drinking of alcohol i.e. alcohol abuse as determined by the Fast Alcohol Screening Test (FAST)
32. Individuals on a severe calorie restricted diet \<800cals/day
33. Has a surgical procedure booked in the next 12 months
34. Has a history of chronic pancreatitis
35. Has latent autoimmune diabetes in adults (LADA)
36. Individuals on loop diuretics
37. Any contraindication to the IMP
B: 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"
C: Inclusion Criteria:

* Muslim, with type 2 diabetes mellitus
* Intends to fast during the month of Ramadan
* Hemoglobin A1c (HbA1c) ≤10% at screening
* On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Exclusion Criteria:

* Type 1 diabetes mellitus
* Pregnant or breast feeding or with gestational diabetes
* Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
* Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
* History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
* Any use of insulin (prior to or during Ramadan)
* Use of any class of oral antidiabetic therapy other than an SU or metformin
* Current participation in another interventional study
D: 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

Answer: C