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

March 2, 2016 updated by: Novo Nordisk A/S

Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycaemic haemoglobin)
Fasting plasma glucose (FBG)

Secondary Outcome Measures

Outcome Measure
Hypoglycaemic episodes
Body weight change
Adverse drug reactions (ADR)
Serious adverse drug reactions (SADR)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1893

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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