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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00849342
First received: February 20, 2009
Last updated: August 13, 2014
Last verified: July 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in body weight and BMI [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in waist perimeter [ Time Frame: from insulin start and after 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: from 12 and 6 months before treatment after 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Change in HbA1C [ Time Frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events during 4 weeks proceeding routine visits [ Time Frame: after 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Number of adverse drug reactions (ADR) [ Time Frame: after 6 and 12 months of treatment ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: from insulin start and 6 and 12 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 580
Study Start Date: December 2008
Study Completion Date: January 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849342

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00849342     History of Changes
Other Study ID Numbers: NN304-3708
Study First Received: February 20, 2009
Last Updated: August 13, 2014
Health Authority: Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate
Slovenia: Not required for observational study

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

ClinicalTrials.gov processed this record on October 29, 2014