Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
* For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
* For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
* HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)
B: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
C: Inclusion Criteria:

* Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes Association as either:

  1. presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random of greater than 200 mg/dL (11mmol/L) or
  2. fasting plasma glucose elevation on more than one occasion of at least 126 mg/dL (7mmol/L)
* Currently undergoing pharmacological or non-pharmacological treatment for diabetes
* Angiographically confirmed multivessel CAD \[critical (greater than or equal to 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)\] amenable to either PCI or CABG
* Angiographic characteristics amendable to both PCI/DES and CABG
* Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia

Exclusion Criteria:

* Severe congestive heart failure (class III or IV according to New York Heart Association \[NYHA\] or pulmonary edema)
* Prior CABG surgery
* Prior valve surgery
* Prior PCI with stent implantation within 6 months of study entry
* Stroke within 6 months of study entry; if stroke occurred more than 6 months prior to study entry, must have significant residual neurologic involvement, as reflected in a Rankin Score of greater than 1
* Prior history of significant bleeding (within 6 months of study entry) that may occur during CABG or PCI/DES related anticoagulation
* In-stent restenosis of a target vessel
* Two or more chronic total occlusions in major coronary territories
* Left main stenosis (at least 50% diameter stenosis)
* Acute ST-elevation MI (Q-wave) within 72 hours of study entry requiring revascularization
* Abnormal creatine kinase level (greater than twice the normal limit); or abnormal CK-MB level at study entry
* Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g., valve repair/replacement, aneurysmectomy, carotid endarterectomy, or carotid stent)
* Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
* Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* Intolerance to aspirin or both clopidogrel and ticlopidine
* Dementia with a score of less than 20 on the Mini Mental Status Examination (MMSE)
* Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g., oxygen-dependent chronic obstructive pulmonary disease, active hepatitis, significant hepatic failure, or severe kidney disease)
* Pregnant
* Currently enrolled in another clinical trial
* Unable to attend required follow-up visits
D: Inclusion criteria:

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycemia during Run-in
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
5. Unsufficient birth control, pregnancy and nursing

Answer: D