- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849342
Observational Study on Levemir® in Obese Diabetic Patients (KILOS)
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
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alphen a/d Rijn, Netherlands
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Ljubljana, Slovenia, SI-1000
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diabetes mellitus (Type 1 or type 2)
- BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy
Exclusion Criteria:
- Subjects currently being treated with insulin detemir
- Subjects who were previously enrolled in this study;
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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A
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Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in body weight and BMI
Time Frame: during 12 months of treatment
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during 12 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
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Change in waist perimeter
Time Frame: from insulin start and after 6 and 12 months of treatment
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from insulin start and after 6 and 12 months of treatment
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Change in FPG (Fasting Plasma Glucose)
Time Frame: from 12 and 6 months before treatment after 6 and 12 months of treatment
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from 12 and 6 months before treatment after 6 and 12 months of treatment
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Change in HbA1C
Time Frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
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from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
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Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
Time Frame: after 6 and 12 months of treatment
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after 6 and 12 months of treatment
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Number of adverse drug reactions (ADR)
Time Frame: after 6 and 12 months of treatment
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after 6 and 12 months of treatment
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Change in blood pressure
Time Frame: from insulin start and 6 and 12 months after treatment
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from insulin start and 6 and 12 months after treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-3708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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