NCT00862875

Trial name or title	Effects of basal insulin analogue detemir on body composition, epicardial fat and energy metabolism.
Methods	Intervention study, randomised, open‐label, parallel assignment, pharmacodynamics study.
Participants	Inclusion criteria: Type 2 diabetic patients who require basal (long‐acting) insulin for the control of hyperglycaemia according to the opinion of the investigator, age 18 to 80 years, BMI from 27 to 40 kg/m2, HbA1c ≥ 8.0% to 12.0%, stable body weight for previous 3 months (± 5 kg), structured exercise < 4 hours per week, and 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, previous treatment with insulin (< 6 months prior inclusion), secondary diabetes (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.), maturity‐onset diabetes of the young, proliferative retinopathy/maculopathy requiring treatment, hypoglycaemia unawareness or recurrent major hypoglycaemia, pregnancy or 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, TIA, ventricular arrhythmias, or unstable supra‐ventricular arrhythmias, renal insufficiency (creatinine clearance < 40 ml/min), acute (< 2 months) or chronic infectious diseases requiring either hospitalisation or antibiotic treatment for > 2 weeks, recent (< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer, major psychiatric diseases, history of drug addiction, previous bariatric surgery or medication that affects weight.
Interventions	Insulin detemir: Initial dose of 10 units of insulin at bedtime. The insulin dose will be increased by 1 unit per day until FPG levels are 5.0 mmol/L. Insulin glargine: Initial dose of 10 units of insulin at bedtime. The insulin dose will be increased by 1 unit per day until FPG levels are 5.0 mmol/L.
Outcomes	Changes in total fat mass, and epicardial fat, trunk fat, total fat free mass, weight and waist circumference, HbA1c, fasting glucose, RMR, TEF, PAEE and TEE and energy intake.
Starting date	March 2009.
Contact information	Sylvie Blaquiere (sylvie.blaquiere@ircm.qc.ca) or Stephanie Potvin (stephanie.potvin@ircm.qc.ca).
Notes	Estimated completion date: December 2011.