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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2289
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult Type 2 Diabetes Mellitus patients on intensive insulin treatment

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.
  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: NCT00657930

Locations
Hungary
Budapest, Hungary, H-1025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Varnai Varnai, MD Novo Nordisk Hungary Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00657930     History of Changes
Other Study ID Numbers: NN304-3526
Study First Received: April 8, 2008
Last Updated: June 27, 2012
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014