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

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ClinicalTrials.gov Identifier: NCT00697450
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 206 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00697450


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00697450     History of Changes
Other Study ID Numbers: NN304-3560
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 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