Observational Study of NovoNorm® in Subjects With Diabetes

February 17, 2017 updated by: Novo Nordisk A/S

NovoNorm Post Marketing Surveillance Study

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5841

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Korean people with diabetes mellitus

Description

Inclusion Criteria:

  • Type 2 diabetes

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
Repaglinide
Drug: repaglinide
Prescription with NovoNorm® 0.5mg, 1mg or 2mg tablets according to product labelling in daily clinical practice at the discretion of the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)
Body weight
2 hours postprandial blood glucose (2-hr PPBG)
Fasting blood glucose (FBG)

Secondary Outcome Measures

Outcome Measure
Adverse events

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 (ACTUAL)

August 30, 2001

Primary Completion (ACTUAL)

March 25, 2005

Study Completion (ACTUAL)

March 25, 2005

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (ESTIMATE)

December 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGEE-1882

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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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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