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 A/S
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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542463

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

Additional Information:
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 July 20, 2014