Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy
Brief Summary: To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.


Options:
A: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Female or male, 18 years≤age≤70years
* Subjects with insulin naïve type 2 diabetes who have been treated with metformin（\>1g/d）alone for at least 3 months prior to screening
* 11%≥HbA1c≥7.5% based on analysis from a central laboratory
* 24kg/m2≤BMI≤40kg/m2
* Weight fluctuation\<2kg in one month prior to screening
* Able and willing to perform self-monitoring of blood glucose.
* Willing to accept basal insulin therapy
* Able to self-inject all required doses of insulin

Exclusion Criteria:

* Treatment with any OADs (Oral Antidiabetic Drugs) in the last 6 months, except metformin (subjects currently treated with metformin within the interval of 1000-2000 mg daily may be included in the trial. The dose should have remained unchanged for a period of one month prior to randomisation and should be expected to remain unchanged throughout the trial period).
* Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramine, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, NSAIDs, tricyclic anti-depressants, atypical anti-psychotics).
* Participation in a clinical study of weight control within the last 3 months prior to screening.
* Previous or planned surgical treatment of obesity.
* Any disease or condition (such as renal, hepatic or cardiac) according to the judgment of the Investigator makes the subject unsuitable for participation in the trial.
* Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
* Anticipated change in concomitant medication known to interfere with lipid metabolism, such as lipid-lowering drugs.
* Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
* Uncontrolled hypertension (treated or untreated) as judged by the Investigator
* Known or suspected allergy to trial product(s) or related products.
* Previous participation in this trial. Participation is defined as screened.
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
* Receipt of any investigational drug (NPH or insulin detemir) within 1 month prior to this trial.
* Cardiac disease defined according to NYHA class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection.
* History of hypoglycaemic unawareness.
* With mental implant (such as cardiac pacemaker, insulin pump) in vivo.
B: Inclusion Criteria:

* Male or female, age 18-75
* Type 2 diabetes diagnosed for at least 1 year
* Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of NPH insulin
* Except for the subject's current bedtime NPH insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
* Average fasting plasma glucose level \<130 mg/dL without fasting hypoglycemia
* Hemoglobin A1c between 7.5% and 12%
* Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

* 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 intensive insulin therapy is contraindicated
* Subjects with advanced proliferative diabetic retinopathy
* Subjects 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.
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: C