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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849342
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

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
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
Study Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.

Primary Outcome Measures :
  1. Change in body weight and BMI [ Time Frame: during 12 months of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in waist perimeter [ Time Frame: from insulin start and after 6 and 12 months of treatment ]
  3. Change in FPG (Fasting Plasma Glucose) [ Time Frame: from 12 and 6 months before treatment after 6 and 12 months of treatment ]
  4. Change in HbA1C [ Time Frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment ]
  5. Change in number of hypoglycaemic events during 4 weeks proceeding routine visits [ Time Frame: after 6 and 12 months of treatment ]
  6. Number of adverse drug reactions (ADR) [ Time Frame: after 6 and 12 months of treatment ]
  7. Change in blood pressure [ Time Frame: from insulin start and 6 and 12 months after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00849342

Alphen a/d Rijn, Netherlands
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00849342     History of Changes
Other Study ID Numbers: NN304-3708
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs