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Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir® (LITHULEV1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00806897
First received: December 10, 2008
Last updated: June 28, 2012
Last verified: November 2011
History of Changes
  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 NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Multicentre, Open Label, Non-controlled, 24-week Observation in Type 2 Diabetics Using Once Daily Levemir® (Insulin Detemir) as Part of Their ITT Regimen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: at 12 weeks/24weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Other Names:
  • Levemir®
  • NN304

  Eligibility

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

Diabetic subjects from specialists' (diabetologists, internists) care who are treated with intensive insulin treatment by prescription in line with governing prescribing rules. At baseline subjects are treated with IIT containing NPH as basal insulin.

Criteria

Inclusion Criteria:

  • Type 2 diabetic subjects on intensive insulin treatment (IIT)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806897

Locations
Lithuania
Vilnius, Lithuania, 08119
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Arunas Teiberis, MD UAB Novo Nordisk Pharma
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00806897     History of Changes
Other Study ID Numbers: NN304-3701
Study First Received: December 10, 2008
Last Updated: June 28, 2012
Health Authority: Lithuania: Lithuanian Bioethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013