Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
Brief Summary: Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Options:
A: Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
* HbA1c 7-10% (both inclusive)
* Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
* Body Mass Index (BMI) 20-45 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
* Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
* Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
* Heart failure defined as New York Heart Association (NYHA) class IV
* A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
* Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
* Use of immunosuppressive treatment within 90 days prior to screening
* Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
B: Inclusion Criteria:

* Adults ≥18 to ≤80 years of age
* History of T2DM for at least 6 months prior to screening
* Moderate to severe renal impairment and not actively on dialysis
* Willing and able to perform self-monitoring of blood glucose
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)
* Subjects who have received a renal allograft
* Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing
* Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1
* Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2
* History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2
* Subjects with congestive heart failure
* Subjects with uncontrolled Stage III hypertension
* History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2
* History of alcohol or illicit drug abuse within 1 year prior to Screening
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Major surgery within 6 months prior to planned study Day -2
* History of any malignancy within the last 5 years
* Triglycerides \>1000 mg/dL at Screening or planned study Day -1
* History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor
* Use of corticosteroids within 2 weeks prior to study Day 1
* Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1
* Positive urine pregnancy test at Screening
* Positive urine screen for illicit drug abuse at Screening
* Prior exposure to LX4211
C: Eligibility Criteria:

* The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.
D: Inclusion criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

Answer: D