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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01542463
First received: February 24, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c (glycaemic haemoglobin) [ Designated as safety issue: No ]
  • Fasting plasma glucose (FBG) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight change [ Designated as safety issue: No ]
  • Adverse drug reactions (ADR) [ Designated as safety issue: No ]
  • Serious adverse drug reactions (SADR) [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment: 4464
Study Start Date: September 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IDet users Drug: insulin detemir
Prescribed at the discretion of the physician

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542463

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Martin Grundner Novo Nordisk Pharma GmbH
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542463     History of Changes
Other Study ID Numbers: NN304-1893
Study First Received: February 24, 2012
Last Updated: February 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013