Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus
Brief Summary: Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:

* Participant persistence with assigned basal insulin therapy.
* Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.
* Changes in HbA1c, fasting plasma glucose, body weight
* Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).
* Healthcare resource utilization including hospitalizations and emergency department or other 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

* Insulin-naïve type 2 diabetes mellitus
* Type 2 diabetes mellitus diagnosed for at least 1 year
* Treated with at least one OAD (Metformin \[daily dose of at least 1000mg\], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
* HbA1c \> or = 7.0% and \< or = 10.5%
* BMI \< 40 kg/m²
* Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
* Informed consent obtained in writing at enrolment into the study
* Willingness and ability to comply with the study protocol

Exclusion criteria:

* Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
* Treatment with TZD as monotherapy
* Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...)
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
* Impaired renal function: serum creatinine \> or =1.5 mg/dL (\> or = 133µmol/L) or \> or = 1.4 mg/dL (\> or = 124 µmol/L) in men and women, respectively
* History of sensitivity to the study drugs or to drugs with a similar chemical structure
* Impaired hepatic function (ALT and/or AST \> 3 x upper limit of normal range)
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
* Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
* Treatment with an investigational product in the 30 days prior to visit 1
* Alcohol or drug abuse in the last year
* Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient's safety or limit the patient successful participation in the study (including night shift worker)

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

* Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
* Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
* No pre-treatment with any insulin in the last 3 months before the study.
* Glycated Haemoglobin A1c (HbA1c) value between \> or = 7.0 and \> or = 9.5%
* Fasting Blood Glucose (FBG) \> or = 120 mg/dl (6.7 mmol/l).
* Body mass index \< 40 kg/m.
* Ability to read and understand German language.
* Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
* Women of childbearing potential who will take adequate contraceptive protection.

Exclusion criteria:

* Patients with type 1 diabetes mellitus.
* Any history of ketoacidosis.
* Pregnancy.
* Prior treatment with insulin.
* Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.
* History of drug or alcohol abuse.
* Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
* Following pancreatectomy.
* Impaired hepatic function.
* Impaired renal function.
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
* Inability to attend follow-up visits.
* Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).
* Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
* Systemic corticoids \> 7,5 mg prednisolon equivalent or \<or=7,5 mg prednisolon equivalent for less than 2 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
D: Inclusion criteria :

* Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin).
* Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

* HbA1c \<8.0% or \>11.0%.
* Males or females \<18 years of age.
* 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 participant's successful participation for the duration of the study.
* Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization, or short-term use during acute event.
* Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic, or 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.
* 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 participant's potential participation in a clinical trial.

Answer: D