This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients. Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
Study Type
OBSERVATIONAL
Enrollment
580
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
Unnamed facility
Alphen aan den Rijn, Netherlands
Unnamed facility
Ljubljana, Slovenia
Change in body weight and BMI
Time frame: during 12 months of treatment
Change in body weight at different BMI subgroups
Time frame: at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
Change in waist perimeter
Time frame: from insulin start and after 6 and 12 months of treatment
Change in FPG (Fasting Plasma Glucose)
Time frame: from 12 and 6 months before treatment after 6 and 12 months of treatment
Change in HbA1C
Time frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
Time frame: after 6 and 12 months of treatment
Number of adverse drug reactions (ADR)
Time frame: after 6 and 12 months of treatment
Change in blood pressure
Time frame: from insulin start and 6 and 12 months after treatment
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