Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension
Brief Summary: Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
* To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
* Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events \[as defined by the American Diabetes Association (ADA\] Workgroup on Hypoglycemia).
* Change in fasting plasma glucose (FPG).
* Change in body weight.
* Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
* Change in hypoglycemic control subscale (HCS)
* Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.


Options:
A: Inclusion Criteria:

* type 2 diabetes mellitus for at least 1 year
* treated with oral antidiabetic agents or insulin at stable doses for at least 3 months
* HbA1c between 6 and 12% inclusive
* baseline retinopathy severity not to exceed 53/\<53 on the ETDRS scale
* unlikely to require laser surgery or vitrectomy within upcoming year

Exclusion Criteria:

* prior treatment with insulin glargine
* treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment
B: Inclusion criteria :

Patients with type 2 diabetes insufficiently controlled (HbA1c \>7%) with current (≥6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinediones, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without GLP-1 receptor agonist, and eligible to basal insulin treatment, per investigator's judgment.

Exclusion criteria:

* HbA1c ≤7%, no upper bound.
* Age \<18 years.
* Type 1 diabetes mellitus.
* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
* Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization.
* Use of any product containing insulin occurring within 3 months prior to the time of screening.
* Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP 1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
* All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
* Hypersensitivity to insulin glargine or Toujeo excipients.
* Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Pregnancy or lactation.
* Women of childbearing potential with no effective contraceptive method.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
C: Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion
D: Inclusion Criteria:

* Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.

Exclusion Criteria:

* Angina pectoris, Canadian Class I-II,
* congestive heart failure, Class III-IV,
* stroke, incapacitating or in last 6 months,
* Myocardial infarction (MI) or invasive cardiovascular procedure within the past six months,
* ongoing diabetic gangrene,
* BMI \> 40,
* hemoglobinopathy that interferes with A1c monitoring,
* serum creatinine \> 1.6 mg/dL,
* fasting C-peptide \< 0.21 pmol/ml,
* Alanine Amino Transaminase (ALT) \> 3 times normal or serum bilirubin \> 1.9 mg/dL,
* malignancy or noncardiac life-threatening diseases making life expectancy \< 5 years,
* autonomic neuropathy,
* symptomatic pancreatic insufficiency (endocrine or exocrine),
* recurrent seizures within the past year,
* hypopituitarism,
* pregnancy, lactation, or planning a pregnancy,
* active psychosis or substance abuse,
* lack of access to a person who can assist or be called in an emergency,
* underlying conditions that in the site PI's judgment may prevent adherence to protocol,
* current participation in another clinical trial

Answer: B