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Evaluation of the Use of Levemir® in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes

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.
ClinicalTrials.gov Identifier: NCT01542463
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Design

Study Type : Observational
Actual Enrollment : 4464 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight
Study Start Date : September 2004
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
IDet users Drug: insulin detemir
Prescribed at the discretion of the physician


Outcome Measures

Primary Outcome Measures :
  1. HbA1c (glycaemic haemoglobin)
  2. Fasting plasma glucose (FBG)

Secondary Outcome Measures :
  1. Body weight change
  2. Adverse drug reactions (ADR)
  3. Serious adverse drug reactions (SADR)
  4. Hypoglycaemic episodes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy
Criteria

Inclusion Criteria:

  • Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy
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): NCT01542463


Locations
Germany
Mainz, Germany, 55127
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: NCT01542463     History of Changes
Other Study ID Numbers: NN304-1893
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs