Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes

October 28, 2014 updated by: Novo Nordisk A/S

Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes

This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

314

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

  • Denmark
      • Copenhagen S, Denmark, 2300
  • Sweden
      • Stockholm, Sweden, 182 88

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 aged 18 or above, with type 2 diabetes, who together with their physician, have decided to switch to Levemir® from human basal insulin treatment

Description

Inclusion Criteria:

  • Any patient with type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 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
A
Drug: insulin detemir
Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions, including major hypoglycaemic events
Time Frame: After 26 weeks
After 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks
Weight changes
Time Frame: at 12 and 26 weeks
at 12 and 26 weeks
Number of all adverse drug reactions
Time Frame: after 12 and 26 weeks
after 12 and 26 weeks
Number of all hypoglycaemic events
Time Frame: at 12 weeks and 26 weeks
at 12 weeks and 26 weeks
Variability in fasting plasma glucose (FPG) values and average FPG levels at visits
Time Frame: at 12 and 26 weeks
at 12 and 26 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

March 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1938

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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