Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Brief Summary: To investigate efficacy, safety and tolerability of BI 1356 versus placebo


Options:
A: Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin IR
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
B: Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably\* \>/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
2. Glycosylated haemoglobin A1 (HbA1c) \>/= 7.0 and \</= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
3. Age \>/= 18 and \</= 80 years at Visit 1a (screening)
4. BMI (Body Mass Index) \</= 40 kg/m2 at Visit 1a (screening)
5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation \*Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Exclusion criteria:

1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
3. Renal failure or renal impairment (serum creatinine \>/= 1.5 mg/dl) as determined at Visit 1a
4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
5. Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
6. Treatment with insulin within 3 months prior to the date of informed consent
7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
9. Pre-menopausal women (last menstruation \</= 1 year prior to the date of 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 periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
11. Dehydration (as confirmed by the Investigators clinical opinion)
12. Current acute or chronic metabolic acidosis
C: Inclusion criteria:

* Male or female patients with type 2 diabetes and insufficient glycaemic control.
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
* Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
D: Inclusion Criteria:

* Age equal or above 35 years;
* Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;
* Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;
* Insufficient metabolic control as defined by recent (last six months) HbA1c ≥ 7% in any peripheral laboratory and confirmed at the time of the screening;
* Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);
* Written informed consent to participate to the study.

Exclusion criteria:

* Age below 35 years
* Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
* HbA1c \< 7% or ≥ 9% at the screening visit
* Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit
* BMI \< 20 or ≥ 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorders, etc.)
* Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit
* Significant progression of diabetic micro-angiopathy in the six months prior to study visit
* Organ failure or other severe diseases limiting life expectancy;
* Beginning, in the three months before screening visit, of any kind of drug which can modify glycemic levels (beta-blockers, diuretics...), or acute disease (acute infection, urinary tract infection...) in three months before screening visit
* History of inflammatory/infective/autoimmune chronic disease
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;
* Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at screening that in the judgment of the investigator would preclude safe completion of the study;
* Uncontrolled or inadequately controlled hypertension at screening (Systolic Blood Pressure (SBP)\>190 or Diastolic Blood Pressure (DBP) \>100 mmHg)
* Ongoing pregnancy or absence of effective contraception in women with childbearing potential
* Contraindications to the maintenance of the background therapy (Metformin), including -but not limited to- chronic kidney failure or plasma creatinine concentrations \> 1.5 mg/dL, severe respiratory failure, etc.;
* Contraindications to the use of a Sulfonylurea;
* Contraindications to the use of a DPP-IV Inhibitor;
* Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements:

  1. Hemoglobinopathy known to affect HbA1c assays;
  2. Known chronic liver diseases, including HBV (hepatitis B virus) and HCV (hepatitis C virus) infection;
  3. Liver makers (aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) , bilirubin) above 2 times the upper normal limit;
  4. Amylase and/or lipase above 2 times the upper normal limit;
* Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);
* History of low compliance, clinically-relevant psychiatric disorders or any current/ historical finding suggesting the patient as inappropriate to follow the study procedures.

Answer: C