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 :

* Patients with type 2 diabetes insufficiently controlled (HbA1c \>7%) with current (≥6 months) "standard of care" basal insulin therapy (including insulin glargine U100, Levemir, NPH, or Tresiba) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without use of a GLP-1 receptor agonist.
* Fasting plasma glucose (FPG) \>130 mg/dL (7.2 mmol/L).
* Adult patients who have signed Informed Consent Form (ICF) and privacy form(s).

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 short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization.
* Use of any product containing short or rapid acting 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 "standard of care" 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.
* 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.
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:

* Duration of type 2 diabetes mellitus for at least one year
* Insulin naive patients
* OHA treatment for at least 12 weeks
* HbA1C between 7.5-10.0%
* Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
D: Inclusion Criteria:

* Type 2 diabetes
* Insulin naive
* Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
* HbA1c between 8% - 10.5%

Exclusion Criteria:

* Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
* Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
* Proliferative retinopathy, maculopathy requiring treatment,
* Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
* End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
* Acute disease with poor prognosis
* History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
* Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
* Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
* Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
* Participation in another clinical trial less than one month before inclusion in this trial
* Illness requiring repeated hospitalisation
* Known or suspected allergy to the insulin or any compositional component
* Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
* Terminal illness

Answer: B