Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications


Options:
A: Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Female or male aged ≥18 years at the time of consent
* eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
* Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
* Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

Exclusion Criteria:

* Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
* Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
* History of organ transplantation
* Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes mellitus
* New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
* MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
B: Inclusion Criteria:

1. Provision of informed consent before any trial specific procedures.
2. Diagnosed with type 2 diabetes mellitus based on the current American Diabetes Association guidelines.
3. Aged \>18 and \<80 years
4. Body Mass Index ≥23
5. HbA1c 48-85mmol/mol (last known result within in the previous 6 months)
6. Blood pressure \<145/90mmHg. Office BP at screening visit will be used however if this is above the inclusion criteria then the 24 hour or 16 hour recording at screening visit will be used to confirm that in the opinion of the PI the BP is adequately controlled.
7. Echocardiographic left ventricular (LV) hypertrophy (defined as an LV mass index of \>115g/m2 for men and \>95g/m2 for women indexed to body surface area or \>48g/m2.7 or \>44g/m2.7 when indexed to height) within the previous 6 months.
8. Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.

Exclusion Criteria:

1. 1. Any condition that in the opinion of the investigator may render the participant unable to complete the trial including non CV disease (e.g. active malignancy).
2. Participants with type 1 diabetes mellitus
3. Participants who have previously had an episode of diabetic ketoacidosis.
4. Serum Potassium or Sodium results outwith the normal range
5. Diagnosis of clinical heart failure
6. History of human immunodeficiency virus
7. LV systolic dysfunction (LVEF \<45%) (last known result within in the previous 6 months)
8. eGFR \<45ml/min (last known result within in the previous month)
9. Known liver function tests \>3 times upper limit of normal (based on last measures and documented laboratory measurement in the previous 6 months)
10. Body weight \>150Kg (unable to fit into a MRI scanner)
11. Contraindications to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
12. Past or current treatment with any SGLT2 inhibitor
13. Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
14. Current treatment with loop diuretic
15. Currently receiving long term (\>30 consecutive days) treatment with an oral steroid
16. Pregnant or breast feeding participants
17. Involvement in the planning and/or conduct of the trial (applies to Astra Zeneca or representative staff and/or staff at the trial site).
18. Participation in another interventional study (other than observational trials and registries) within 30 days before visit 1.
19. Individuals considered at risk for poor protocol or medication compliance.
C: Inclusion criteria:

* Male or female patient age \>= 18 years at screening. For Japan only: Age \>= 20 years at screening
* Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) \<=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

  * If EF \>= 36% to \<= 40%: NT-proBNP \>= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP \>= 5000 pg/ml for patients with AF
  * If EF \>= 31% to \<= 35%: NT-proBNP \>= 1000 pg/ml for patients without AF and NT-proBNP \>=2000 pg/ml for patients with AF
  * If EF\<= 30%: NT-proBNP \>= 600 pg/ml for patients without AF and NT-proBNP \>=1200 pg/ml for patients with AF
  * EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP \>= 1200 pg/ml for patients with AF
* Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
* Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
* Signed and dated written ICF (Informed Consent Form)
* Further inclusion criteria apply

Exclusion criteria:

* Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
* Heart transplant recipient, or listed for heart transplant
* Acute decompensated HF
* Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.
* Symptomatic hypotension and/or a SBP \< 100 mmHg
* Indication of liver disease
* Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
* History of ketoacidosis
* Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
* Currently enrolled in another investigational device or drug study
* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Further exclusion criteria apply
D: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
* High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Exclusion Criteria:

* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event \<2months prior to randomisation

Answer: D