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

January 30, 2017 updated by: Novo Nordisk A/S

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1889

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Macedonian people with diabetes mellitus (Type 1 or Type 2)

Description

Inclusion Criteria:

  • Macedonian people with diabetes mellitus (Type 1 or Type 2)

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
BIAsp 30 users
Drug: biphasic insulin aspart 30
Prescribed at the discretion of the physician
IDet users
Drug: insulin detemir
Prescribed at the discretion of the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Fasting plasma glucose (FPG)
Incidence of adverse events
Change in body weight
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)

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.

General Publications

  • Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.

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, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1763

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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