Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
Brief Summary: This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.


Options:
A: Inclusion Criteria:

* Type 2 diabetes mellitus.
* Cardiovascular disease
* Hypertension

Exclusion Criteria:

* Patients with type 1 diabetes or diabetes insipidus
* Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
* Any clinically significant illness, which would compromise the patient's safety and their participation in the study
B: 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
C: Inclusion criteria

1. Be at least 18 years old, male or female
2. Have acute ST segment elevation myocardial infarction (typical chest pain of more than 30 minutes duration, presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block) and/or occluded coronary artery
3. Intervention of infarct related artery by PCI/Stenting within 2-24 hours after onset of acute myocardial infarction.
4. have creatinin kinase elevation of more than three times of upper normal level (i.e. 540 U/l) accompanied by a significant elevation of CK-MB isoenzyme and/or Troponin I/T
5. Have regional wall motion abnormality (comprising hypo-, a- or dyskinesia) of at least one myocardial segment demonstrated with MRI.
6. Patients who are further suitable for coronary angiography and angioplasty with stenting of the infarct related artery.
7. Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.
8. Give a written informed consent.

Exclusion criteria

General:

1. Women of childbearing potential, pregnancy or being lactating.
2. Be unable to undergo percutaneous cardiac catheterisation
3. Have contraindications against magnetic resonance imaging (e.g. non-MR compatible implants or medical devices)
4. Have conditions that may severely degrade image quality (e.g. severe arrhythmia) or prevents from MR scanning (e.g. claustrophobia)
5. Previous enrolment in the present trial or administration of any study medication within the previous 30 days. Study drug is defined as any material (placebo or drug) dispensed under the provisions of a protocol.
6. Have other severe concurrent illness (e.g., active infection, malignancy).
7. Life expectancy of less than one year.
8. Have a history of alcohol or drug abuse within 3 months prior to admission or factors jeopardising follow-up.

Renal, hepatic, metabolic:

1. Moderate to severe renal impairment (Crea level \>1.7 mg/dL or glomerular filtration rate \<35 ml/min).
2. Diabetes type 1 patients.
3. Diabetic ketoacidosis.
4. Concomitant medications known to cause hypoglycemia, such as sulfonylureas.
5. Severe liver dysfunction.

Haematologic:

1. Malignant haematological diseases, i.e. chronic myeloic leukemia (CML) or myelodysplastic syndromes (MDS)
2. Severe congenital neutropenia with cytogenetic abnormalities
3. Known allergic reaction vs. Lenograstim

Cardiovascular:

1. Acute cardiogenic shock
2. Cardiomyopathy with an ejection fraction below 0.25 (i.e. ischemic or dilated cardiomyopathy resulting in congestive heart failure)
3. Infective endocarditis
4. Factors contraindicating cardiac catheterisation (e.g. severe allergy against iodine, severe thyroid disease)
5. Planned operative revascularisation
6. Left ventricular thrombus
7. Severe cardiac arrhythmias (i.e. malignant sustained or non-sustained ventricular tachycardia or ventricular fibrillation) within 24 hours after admission.

Pulmonary:

1. Acute massive pulmonary infiltrations
2. History of pneumonia in the last 4 weeks

Other:

1. Therapy with immunosuppressants, cytostatics, corticoids.
D: Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
3. Glycosylated haemoglobin (HbA1c) of \>= 7.0% and \<=10% for patients on background therapy or HbA1c \>= 7.0% and \<= 9.0% for drug naive patients
4. Age \>= 18 years
5. Body Mass index \<= 45 at Visit 1
6. Signed and dated informed consent
7. High cardiovascular risk

Exclusion criteria:

1. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
3. Planned cardiac surgery or angioplasty within 3 months
4. Impaired renal function, defined as Glomerular Filtration Rate \<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Contraindications to background therapy according to the local label
9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
11. Pre-menopausal women (last menstruation \<+ 1 year prior to informed consent) who:

    * are nursing or pregnant or
    * are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
13. Participation in another trial with an investigational drug within 30 days prior to informed consent
14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent

Answer: A