Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

August 13, 2014 updated by: Novo Nordisk A/S

Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1074

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

  • Switzerland
    • Oerlikon
      • Zurich, Oerlikon, Switzerland, CH-8050

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

Probability Sample

Study Population

Patients from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  • Insulin-naive or currently treated with another basal insulin
  • Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Patients treated with short acting or with premix insulin
  • Women who are pregnant, breast feeding or have the intention to become pregnant
  • Known or suspected allergy to the study product or related product
  • Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)

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
A
Drug: insulin detemir
Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
Other Names:
  • Levemir®
  • NN304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c of treatment
Time Frame: after 12 to 16 weeks
after 12 to 16 weeks
Change in FPG (fasting plasma glucose) of treatment
Time Frame: after 12 to 16 weeks
after 12 to 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: after 12 to 16 weeks
after 12 to 16 weeks
Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation
Time Frame: after 12 to 16 weeks
after 12 to 16 weeks

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

November 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (ESTIMATE)

November 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3694

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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