Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir) (LEONCET2)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00657930
First received: April 8, 2008
Last updated: June 27, 2012
Last verified: September 2011

April 8, 2008
June 27, 2012
March 2008
April 2009   (final data collection date for primary outcome measure)
Efficacy (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00657930 on ClinicalTrials.gov Archive Site
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Hypoglycaemia frequency [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FBG variability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Insulin dose change [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)
Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
Other Name: Levemir®
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
2289
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic subjects on intensive insulin treatment (ICT)
  • Eligibility for once daily insulin detemir administration
  • Informed consent obtained before any observation-related activities

Exclusion Criteria:

  • Known or suspected allergy to insulin detemir
  • Subjects previously enrolled in the observation
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00657930
NN304-3526
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Peter Varnai Varnai, MD Novo Nordisk Hungary Ltd.
Novo Nordisk A/S
September 2011

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