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

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657930


Locations
Hungary
Budapest, Hungary, 1025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00657930     History of Changes
Other Study ID Numbers: NN304-3526
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: March 3, 2016
Last Verified: March 2016

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