Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment (HA-BOT)

November 22, 2016 updated by: Novo Nordisk A/S

Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1032

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

  • Hungary
      • Budapest, Hungary, 1025
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, H-1025
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A non-randomised sample of approximately 1000 subjects with OAD failure from specialists - diabetologists practice who have been deemed appropriate to receive insulin detemir as add-on to OAD therapy as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
  • Patient willing to sign informed consent
  • Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
  • Subjects with hypersensitivity to Levemir® or to any of the ingredients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin detemir
Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.
Other Names:
  • Levemir®
  • NN304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 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 equal to or more than 6.5%
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in FPG (Fasting Plasma Glucose)
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in body weight
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in waist and hip circumference
Time Frame: after 12 weeks and 24 weeks
after 12 weeks 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

February 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3699

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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