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Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00697450
First received: June 11, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Weight effect [ Time Frame: 12 months prior to and 12 months after detemir treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in FPG levels [ Time Frame: 12 months prior and 12 months after detemir treatment ] [ Designated as safety issue: No ]
  • Improvement in HbA1c levels [ Time Frame: 12 months prior and 12 months after detemir treatment ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants Drug: insulin detemir
Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation

  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

Type 2 diabetics

Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Current treatment with insulin NPH or glargine
  • The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with insulin detemir
  • Previous enrolment in this study
  • Hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697450

Locations
Czech Republic
Prague, Czech Republic, 16000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Karel Rychna, MD Novo Nordisk s.r.o.
Study Director: Dana Raabova, MD Novo Nordisk s.r.o.
  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: NCT00697450     History of Changes
Other Study ID Numbers: NN304-3560
Study First Received: June 11, 2008
Last Updated: January 18, 2013
Health Authority: Czech Republic: State Institute for Drug Control

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 June 17, 2013