Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
Brief Summary: This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.


Options:
A: 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
B: Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
C: Inclusion criteria

* History T2 DM
* Severe Renal Impairment

Exclusion criteria

* Glucose ≥ 270 mg/dL (≥15 mmol/L)
* Patients undergoing any method of dialysis
* Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides
D: Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes
* Body mass index (BMI) \>=22 to \<=45 kg/m2, at screening
* Patients must be taking a stable dosage of metformin as monotherapy at screening
* Patients must have a HbA1c between \>=7% and \<=9.5% at Week 2
* Patients must have a fasting plasma glucose (FPG) \<=270 mg/dL (15 mmol/L) at Week -2

Exclusion Criteria:

* Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
* History of diabetic ketoacidosis or type 1 diabetes mellitus
* History of pancreas or beta-cell transplantation
* History of active proliferative diabetic retinopathy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
* Taken thiazolidinedione therapy in the past 16 weeks before screening

Answer: B