Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

November 23, 2016 updated by: Novo Nordisk A/S

Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

342

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

  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Insulin naïve patients with type 2 diabetes treated with oral antidiabetics

Description

Inclusion Criteria:

  • Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria:

  • Type 1 diabetes
  • Previous use of insulin

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
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
B
Drug: insulin NPH
Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight change
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemic events
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Changes in glycaemic parameters
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Safety parameters by collecting (serious) adverse events and the pregnancies.
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Changes in doses
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
HbA1c
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline
Changes in daily blood glucose values
Time Frame: at 3 months and 6 months after baseline
at 3 months and 6 months after baseline

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

May 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1896

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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