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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 11, 2008
Last updated: November 22, 2016
Last verified: November 2016
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:

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

Primary Outcome Measures:
  • Weight effect [ Time Frame: 12 months prior to and 12 months after detemir treatment. ]

Secondary Outcome Measures:
  • Improvement in FPG levels [ Time Frame: 12 months prior and 12 months after detemir treatment ]
  • Improvement in HbA1c levels [ Time Frame: 12 months prior and 12 months after detemir treatment ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetics

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
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Please refer to this study by its identifier: NCT00697450

Czech Republic
Novo Nordisk Investigational Site
Prague, Czech Republic, 16000
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00697450     History of Changes
Other Study ID Numbers: NN304-3560
Study First Received: June 11, 2008
Last Updated: November 22, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 17, 2017