Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Brief Summary: The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.


Options:
A: Inclusion Criteria:

* Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
* Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb \> 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
* Being ambulatory
* Age: 30 to 80 years
* Proven absence of Islet Antibodies, if QI \< 28 kg/m2
* Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
* Standard dietary prescription by the dietician
* Absence of keto-acidosis
* Informed consent

Exclusion Criteria:

* Congestive heart failure, NYHA-classes III or IV
* Cardiac failure and/or myocardial infarction in the last four months before enrolment
* Other severe organic / systemic disease
* Metformin-induced lactic-acidosis
* Intolerance to metformin hydrochloride
* Renal disease or renal dysfunction
* Hypoxic states
* Severe hepatic dysfunction
* Excessive alcohol intake, acute or chronic
* Acute or chronic metabolic acidosis
B: Inclusion Criteria:

* Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL
* Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (\>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).
* General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula

Exclusion Criteria:

* Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;
* Daily use of neutralizing antacids (e.g. Maalox®)
* Inability to ingest oral medication
* Clinically significant laboratory value at screening
* Hypersensitivity or allergic reaction to vitamin B12
* Participation in a clinical research study involving a new chemical entity within 30 days of the first study dose
* Folate levels below the reference range provided by the clinical laboratory.
* Renal insufficiency
* Vitamin B6 deficiency
C: Inclusion Criteria:

* General practitioner's prescription for Vitamin B12 deficiency testing
* Age\> 18 years
* Ability to give written informed consent
* Vitamin B12 serum concentrations \< 200pmol/l
* indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion Criteria:

* Patients with incorrect intake of vitamin preparations containing vitamin B12
* Patients with previously diagnosed dementia
* Patients with known hereditary transcobalamin transportation defects
* lack of written and/or oral understanding in German, French, Italian or English languages
D: Inclusion Criteria:

* ≥ 65 aged patients with Cobalamin Deficiency.
* Patients give inform consent.

Exclusion Criteria:

* Treatment with B12 (1 last year)
* Neurologic or psychiatric pathologies
* Folic acid \< 2.3ng/ml ...

Answer: A