Observational Study on Levemir® in Obese Diabetic Patients (KILOS)

August 13, 2014 updated by: Novo Nordisk A/S

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight and BMI
Time Frame: during 12 months of treatment
during 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
after 6 and 12 months of treatment
Number of adverse drug reactions (ADR)
Time Frame: after 6 and 12 months of treatment
after 6 and 12 months of treatment
Change in blood pressure
Time Frame: from insulin start and 6 and 12 months after treatment
from insulin start and 6 and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

July 1, 2014

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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