Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Sitagliptin Plus Granulocyte-colony Stimulating Factor in Patients Suffering From Acute Myocardial Infarction
Brief Summary: Trial design:

This Phase III, investigator-driven, randomised, placebo-controlled efficacy and safety study will compare the effects of Sitagliptin in combination with granulocyte-colony stimulating factor (Lenograstim, G-CSF) on the improvement of myocardial function in patients undergoing routine percutaneous coronary revascularisation for acute myocardial infarction (time from onset of infarction to intervention 2 to 24 hours). The primary objective of this study is to compare between a treatment of G-CSF plus Sitagliptin, (G-CSF/Sitagliptin treatment group, n=87) versus Placebo (control treatment group, n=87) in change of global myocardial function from baseline to 6 months of follow-up.


Options:
A: 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.
B: Inclusion Criteria:

* Type 2 diabetes treated with one or more oral agents
* Persistent fasting glucose \> 140 mg/dl or HbA1c \> 7%
* Stable and maximally effective doses of one or more oral agents for 3 months
* Presence of diabetic peripheral neuropathy
* Age between 18 and 70 years
* No risk factors or other causes of neuropathy
* Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration

Exclusion Criteria:

* Nursing mothers or pregnant women
* A history of previous kidney, pancreas or cardiac transplantation
* A past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis C, end stage renal disease, lupus)
* Amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity
* HbA1c \> 10%
* Participation in an experimental medication trial within 3 months of starting the study.
* Undergoing therapy for malignant disease other than basal- or squamous cell carcinoma
* Requiring long-term glucocorticoid therapy
* Inability or unwillingness to comply with the protocol
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:

* Patient has type 2 diabetes mellitus
* Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
* Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Exclusion Criteria:

* Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
* Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
* Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
* Patient has a planned or anticipated revascularization procedure.
* Pregnancy or planned pregnancy during the trial period.
* Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2.
* Patient has a history of gastroparesis or pancreatitis.
* Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of \>40 ng/L at baseline.

Answer: C