Please select the eligibility criteria that correspond to the clinical trial below.
Title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
Brief Summary: Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

* Plasma glucose (fasting, nocturnal) over time,
* Changes from baseline in HbA1c over time,
* Percentage of patients who reach the target of HbA1c \<7 and \<6.5,
* Use of prandial insulin as rescue medication at month 6,
* Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
* Daily dose of insulin,
* Change in body weight from baseline,
* Evolution of 8-point plasma-glucose (PG) profiles,
* Overall safety,
* Patient reported outcomes (treatment satisfaction).


Options:
A: Inclusion Criteria:

* HbA1c: 7.5-11.0%
* BMI: 25-40 kg/m2

Exclusion Criteria:

* Treatment with any OAD (Oral Antidiabetic Drugs) except metformin
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 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.
D: 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

Answer: B