An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries (BO2NE)

December 6, 2016 updated by: Novo Nordisk A/S

A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2155

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

  • Israel
      • Kfar Saba, Israel, 44425
        • Novo Nordisk Investigational Site
  • Jordan
      • Amman, Jordan, 11844
        • Novo Nordisk Investigational Site
  • Lebanon
      • Amman, Lebanon, 11844
        • Novo Nordisk Investigational Site
  • Pakistan
      • Karachi, Pakistan
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any subject with type 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.

Description

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods

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
Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.
Other Names:
  • Levemir®
  • NN304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of hypoglycaemic events from baseline
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
HbA1c
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects to reach HbA1c between 6.5 and 7.0%
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
Glucose variability as measured by FPG
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
Postprandial glycaemic control as measured by PPG
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
Insulin dose and number of injections
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
Body weight
Time Frame: at 12 and 24 weeks
at 12 and 24 weeks
Number of adverse drug reactions (ADR)
Time Frame: at 12 and 24 weeks
at 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

April 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (ESTIMATE)

February 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3735

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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