Levemir-Body Composition and Energy Metabolism

Inclusion criteria

• Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator.
• Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0%
• Stable body weight for previous 3 months (± 5 kg).
• Structured exercise lower than 4 hours per week.
• Metformin ≥1.5 g/day

Exclusion criteria

• Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
• Type 1 Diabetes Mellitus
• Previous treatment with insulin (< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable.
• Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young
• Proliferative retinopathy/maculopathy requiring treatment
• Hypoglycemia unawareness or recurrent major hypoglycaemia
• Pregnancy and breast-feeding
• Unstable coronary artery disease
• Heart Failure as defined by class IV according to NYHA classification
• Recent (< 6 months) history of myocardial infarction, stroke or T.I.A, ventricular arrhythmias, or unstable supra-ventricular arrhythmias.
• Renal Insufficiency. Creatinine clearance < 40 ml/min (MDRD formula).
• Acute (< 2 months) or Chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks
• Recent (< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer
• Major psychiatric diseases
• History of drug addiction
• Previous bariatric surgery
• Medication that affects weight such as

• Systemic corticosteroids (prednisone)
• Anti-obesity medication (Xenical® or Meridia®)
• Megace ®
• Antidepressant medication associated with significant weight impact such as Zyprexa®, Remeron® based on investigator judgment.
• Growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment
• Medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.