Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

December 29, 2023 updated by: Novo Nordisk A/S

Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

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

Sampling Method

Non-Probability Sample

Study Population

Type 1 and Type 2 Diabetes Mellitus

Description

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed
  • Age: Levemir® above 6 years
  • Age: Novomix® above 18 years

Exclusion Criteria:

  • Current treatment with NovoMix® 30 or Levemir®

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
A
Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoMix® 30
B
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycaemic control as measured by HbA1c
Time Frame: After 24 weeks
After 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects to reach HbA1c below 7.0% and =6.5%
Time Frame: After 24 weeks
After 24 weeks
Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30
Time Frame: After 24 weeks
After 24 weeks
The effect on glycamic control as measured by FPG
Time Frame: After 24 weeks
After 24 weeks
The effect on glycamic control as measured by PG profile
Time Frame: After 24 weeks
After 24 weeks
Change in body weight
Time Frame: After 24 weeks
After 24 weeks

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), 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

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimated)

May 2, 2008

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1964

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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