Weight gain, eating patterns, and development of body composition during initiation of basal insulin therapy: a comparison of insulin detemir and insulin glargine

INTERVENTION: Trade Name: Levemir Pharmaceutical Form: Solution for injection Trade Name: Lantus Pharmaceutical Form: Solution for injection CONDITION: Typ 2 diabetes ; MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus PRIMARY OUTCOME: Main Objective: The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today’s standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine. Primary end point(s): To describe changes in hepatic fat content between groups Secondary Objective: ‐ To describe the weight change from baseline to month 12 between groups; ‐ To evaluate HbA1c between groups; ‐ To evaluate changes in body fat and visceral adipose tissue between groups; ‐ To describe changes in waist and hip circumferences between groups; ‐ To describe changes in eating behaviour and food selection between groups; ‐ To describe changes in well being and disease perception between groups; ‐ To evaluate the daily insulin dose between groups; ‐ To describe the fasting blood glucose between groups; ‐ To evaluate hypoglycaemia between groups; ‐ To evaluate safety between groups; INCLUSION CRITERIA: ‐ Age > 18 years and < 80 years ‐ Gender: female, male ‐ Type 2 diabetes ‐ BMI: 20.0 – 38.0 (higher, if MRI is possible) ‐ Anti‐GAD antibody negative ‐ Fasting blood glucose > 126 mg/dl ‐ HbA1c 7.0 – 11.0% ‐ Previous therapy with metformin or sulfonylurea or glinide or a combination of metformin with sulfonyurea or metformin with glinide. ‐ Minimal dose per day: 3.5mg Glibenclamid, 3mg Glimepirid, at least 1500mg Metformin, 3mg Repaglinid, 300mg Nateglinid, 60mg Gliclazid MR ‐ Stable oral therapy for at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range