Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 20, 2009
August 13, 2014
December 2008
April 2011   (final data collection date for primary outcome measure)
Change in body weight and BMI [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00849342 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study on Levemir® in Obese Diabetic Patients
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
A
Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
580
January 2013
April 2011   (final data collection date for primary outcome measure)

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.
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Slovenia
 
NCT00849342
NN304-3708
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP