Observational Study on Levemir® in Obese Diabetic Patients (KILOS)
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.
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2||Drug: insulin detemir|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins|
- 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 ]
|Study Start Date:||December 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Drug: insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849342
|Alphen a/d Rijn, Netherlands|
|Ljubljana, Slovenia, SI-1000|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|