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

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.
 
ClinicalTrials.gov Identifier: NCT00657930
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date April 8, 2008
First Posted Date April 14, 2008
Last Update Posted Date March 3, 2016
Study Start Date March 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2008)		 Efficacy (HbA1c) [ Time Frame: 24 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 11, 2008)
  • Body weight [ Time Frame: 24 weeks ]
  • Hypoglycaemia frequency [ Time Frame: 24 weeks ]
  • FBG variability [ Time Frame: 24 weeks ]
  • Insulin dose change [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)
Official Title 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention Drug: insulin detemir
observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
Other Name: Levemir®
Study Groups/Cohorts A
Intervention: Drug: insulin detemir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2009)		 2289
Original Estimated Enrollment
 (submitted: April 11, 2008)		 1000
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT00657930
Other Study ID Numbers NN304-3526
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Public Access to Clinical Trials, Novo Nordisk A/S
Current Study Sponsor Novo Nordisk A/S
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2016