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

November 22, 2016 updated by: Novo Nordisk A/S

Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

206

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

  • Czech Republic
      • Prague, Czech Republic, 16000
        • Novo Nordisk Investigational Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetics

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight effect
Time Frame: 12 months prior to and 12 months after detemir treatment.
12 months prior to and 12 months after detemir treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in FPG levels
Time Frame: 12 months prior and 12 months after detemir treatment
12 months prior and 12 months after detemir treatment
Improvement in HbA1c levels
Time Frame: 12 months prior and 12 months after detemir treatment
12 months prior and 12 months after detemir treatment

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

July 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3560

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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