Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
Brief Summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Options:
A: Inclusion Criteria:

* Age: 40 to 80 years
* Early diabetes (postchallenge diabetes (2h glucose \>200 mg/dl or type 2 diabetes treated with diet only or on a stable dose of metformin monotherapy)
* Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer tomography)

Exclusion Criteria:

* Acute coronary syndrome or cerebrovascular event within the previous 4 weeks
* Body Mass Index (BMI) \> 35 kg/m2
* HbA1c \<6.0% (42 mmol/mol)
* Serum creatinine \> 2.5 mg/dl
* Aspartate Transaminase (AST)/Alanine Transaminase (ALT)\>3x upper limit of normal
* HbA1c \>9.0% (\>75 mmol/mol)
* Heart failure \> New York Heart Association (NYHA) class II
* Uncontrolled hypertension (blood pressure \> 165 / 100 mmHg)
* Treatment with orally administered steroids
* New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous 6 weeks
* Known Malignancy
* Pregnancy or breast feeding women.
B: Inclusion Criteria:

* Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL)
* BMI \>= 24 kg/m2

Exclusion Criteria:

* Underlying disease likely to limit life span and/or increase risk of interventions
* Conditions or behaviors likely to effect conduct of the DPP
* Diabetes or disordered glucose metabolism
* Suboptimally treated Thyroid disease
* Fasting triglyceride level \< 600 mg/dl
* Exclusions related to medications
C: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Female or male aged ≥40 years
* Diagnosed with Type 2 Diabetes
* High Risk for Cardiovascular events

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
* Chronic cystitis and/or recurrent urinary tract infections
* Pregnant or breast-feeding patients
D: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed
* Subjects with alanine aminotransferase above 2.5 x upper normal limit
* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
* History or presence of pancreatitis (acute or chronic)
* History of diabetic ketoacidosis
* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m\^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Answer: C