Please select the eligibility criteria that correspond to the clinical trial below.
Title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
Brief Summary: The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.


Options:
A: Inclusion Criteria:

* Give written informed consent.
* Patient consents that his/her family physician/diabetologist will be informed of trial participation
* Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
* Experienced in self blood glucose measurement for ≥ 3 months.
* HbA1c ≤ 9% and \>6,5%
* BMI \> 30 kg/m²
* Age ≥ 18 years
* Waist circumference \> 88 cm (female) and \> 102 cm (male)
* NPH insulin treatment plus 1 or 2 OAD (except TZD)

Exclusion Criteria:

* History of drug or alcohol abuse within the last five years prior to screening
* Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
* History of severe or multiple allergies
* Treatment with any other investigational drug within 3 months prior to screening
* Progressive fatal disease
* History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dl in women and \>1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
* Pregnant or lactating women
* Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
* Treatment with GLP1-analog or Thiazolidinediones (TZD)
* hsCRP \> 10 mg/l (by rapid test at screening visit).
* Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
* Type 1 Diabetes mellitus
* Patients already treated with intensified conventional insulin therapy.
B: Inclusion Criteria:

1. Type 2 diabetes
2. Treated with metformin
3. Already on treatment with a long-acting or intermediate insulin.
4. Over 18 years of age,
5. HbA1c \> 7.0%
6. BMI 27-40
7. Able and willing to perform self-blood glucose monitoring.
8. Able and willing to maintain consistent eating habits throughout the entire trial period.
9. Able and willing to maintain consistent physical activity level during the entire trial period

Exclusion Criteria:

1. Patients on sulphonylureas or thiazolidinediones
2. Proliferative retinopathy that has required acute treatment within the last six months.
3. Impaired hepatic or renal functions.
4. Cardiac problems.
5. Uncontrolled hypertension (treated or untreated).
6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
C: Inclusion Criteria:

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

Exclusion Criteria:

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

Answer: A