Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

October 27, 2016 updated by: Novo Nordisk A/S

Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6500

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

Patients with Type 2 diabetes

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Current treatment with human soluble insulin, insulin NPH or premixed human insulin
  • The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Previous enrolment in this study
  • Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

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 aspart
Intervention at the discretion of the physician
Other Names:
  • NovoRapid®
B
Drug: insulin detemir
Intervention at the discretion of the physician
C
Drug: biphasic insulin aspart 30
Intervention at the discretion of the physician
D
Drug: insulin aspart
Intervention at the discretion of the physician
Other Names:
  • NovoRapid®
Drug: insulin detemir
Intervention at the discretion of the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c after switch from human insulin to modern insulin treatment
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% at approximately 12 weeks and 24 weeks of treatment
Time Frame: After 12 and 24 weeks
After 12 and 24 weeks
Postprandial glycaemic control as measured by PPG
Time Frame: After 12 and 24 weeks
After 12 and 24 weeks
Glucose variability as measured by FPG
Time Frame: After 12 and 24 weeks
After 12 and 24 weeks
Insulin dose and number of injections
Time Frame: After 12 and 24 weeks
After 12 and 24 weeks
Body weight
Time Frame: After 12 and 24 weeks
After 12 and 24 weeks
Number of hypoglycaemic events
Time Frame: During treatment
During treatment
Number of adverse drug reactions (ADR)
Time Frame: After 12 and 24 weeks
After 12 and 24 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

January 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (ESTIMATE)

May 2, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3517

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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