Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus
Brief Summary: This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.


Options:
A: Inclusion Criteria:

* Type 2 diabetes for at least 12 months since diagnosis
* Insulin naive subjects
* OAD treatment for at least 4 months alone or combined with no more than two OADs
* Body mass index (BMI) below 35.0 kg/m2
* HbA1c between 7.5-10.0%
* Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

* Current or previous treatment with thiazolidiones within the last 6 months
* OAD treatment with three or more OADs within the last 6 months
* Acute insulin treatment for longer than 7 days in a row within the last 6 months
* Secondary diabetes
* Known maturity onset of diabetes of young (MODY)
* Known or suspected allergy to trial product or related products
B: Inclusion Criteria:

* Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
* Body mass index between 26 and 40 kg/m2
* HbA1c between 7.5% and 10.0%
* Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L
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:

* 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.

Answer: A