Observational Study on Levemir® in Obese Diabetic Patients (KILOS)
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|ClinicalTrials.gov Identifier: NCT00849342|
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : August 15, 2014
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.
|Condition or disease||Intervention/treatment|
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2||Drug: insulin detemir|
|Study Type :||Observational|
|Actual Enrollment :||580 participants|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||January 2013|
Drug: insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849342
|Alphen a/d Rijn, Netherlands|
|Ljubljana, Slovenia, SI-1000|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|