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 Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension
Brief Summary: Primary Objective:

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

Secondary Objectives:

* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by 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 documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).
* 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 :

* Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
* Signed written informed consent.

Exclusion criteria:

* Age \<18 years.
* HbA1c \<7.5% or \>10.5% (at screening visit). Body mass index (BMI) \<25 kg/m\^2 or \>40 kg/m\^2.
* History of T2DM for less than 1 year before screening.
* Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
* Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
* Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
* Participant receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
* History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
* End stage renal disease.
* Any acute or chronic condition that in the opinion of Investigator would affect the safety of participant, compliance, or study results.
* Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
* Pregnant or breast-feeding women.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
C: Inclusion Criteria:

* Male or female, age 18-75
* Type 2 diabetes diagnosed for at least 1 year
* Treatment with stable doses of oral agents (alone or in combination) for at least 2 months
* Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
* No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
* Hemoglobin A1c between 7.5% and 12%
* Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
* History of confirmed (or clinical suspicion of) type 1 diabetes
* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
* Current pregnancy or lactation.
* Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
* Subjects with advanced proliferative diabetic retinopathy
* Subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
* History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
* Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
* Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
D: 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.

Answer: D