NCT00656422

Trial name or title	Weight gain, eating patterns and development of body composition during initiation of basal insulin therapy in patients with type 2 diabetes: a comparison of insulin detemir and insulin glargine.
Methods	Intervention study, supportive care, randomised, open‐label, active‐control, parallel assignment.
Participants	Inclusion criteria: Age > 18 years and < 80 years, type 2 diabetes, BMI between 20.0 and 38.0 kg/m2, anti‐GAD antibody negative, FBG > 126 mg/dl, HbA1c between 7.0% and 11.0% and need for insulin therapy. Exclusion criteria: Previous therapy with insulin within the last 3 months prior to inclusion into the study, previous therapy with glitazones within the last 6 months prior to inclusion into the study, change in therapy with lipid‐lowering or anti‐hypertensive agent within one month prior to inclusion into the study, concomitant participation in other clinical trials, type 1 diabetes, cardiac and macrovascular disease, malignancy including leukaemia and lymphoma within the last 5 years, liver disease (cirrhosis or chronic active hepatitis, except fat liver), significant renal dysfunction, other endocrine disease, significant laboratory abnormalities, history of active substance abuse (including an average alcohol consume of > 40g/day and drugs) within the past 2 years, pregnancy or childbearing potential without adequate contraception, present therapy with systemic steroids, presence of psychiatric disorder or intake of anti‐depressive or anti‐psychotic agents with the exception of benzodiazepines and SSRIs/SNRIs, use of anti‐obesity drugs 3 months prior or during the trial, subjects judged by the investigator to be unsuitable for the study, contraindications for MRI scanning (cardiac pacemaker, implants out of metal or claustrophobia) or known hypersensitivity to insulin detemir, insulin glargine or to any of the other components.
Interventions	Insulin detemir: the participant will receive an insulin dose of insulin detemir at dinner subcutaneously according to a dosing algorithm. Insulin glargine: the participant will receive an insulin dose of the insulin glargine at dinner subcutaneously according to a dosing algorithm.
Outcomes	Changes in hepatic fat content, weight, body fat, visceral adipose tissue, waist circumference, hip circumference, eating behaviour, food selection, well‐being and disease perception. Also, daily insulin dose, fasting BG, hypoglycaemia and safety.
Starting date	November 2007.
Contact information	Prof. dr. Andreas Fritsche (andreas.fritsche@med.uni‐tuebingen.de).
Notes	Estimated completion date: October 2010..