Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Options:
A: Inclusion Criteria:

* Type 2 diabetes mellitus
* Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
* If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
* Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
* Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
* Body mass index of 45 kg/m² or lower
* Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion Criteria:

* Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Active liver disease
* Anemia
* Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
* Use of short- or rapid-acting insulin
* Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
* Congestive heart failure
* Unstable or rapidly progressing renal disease
* History of alcohol or drug abuse within the previous year
* History of hemoglobinopathies
* Unstable major psychiatric disorders
* Immunocompromised status
B: Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
C: 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
D: Inclusion Criteria:

* Type 2 diabetes
* Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
* HbA1c greater than or equal to 7.0% and less than 10.0%
* BMI (Body Mass Index) less than 35 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last 12 weeks
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Answer: B