Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

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

Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1531

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

  • Indonesia
      • Jakarta, Indonesia, 12520
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

  • Subjects who are unlikely to comply with the protocol
  • Subjects who are currently being treated with Levemir®
  • Subjects who previously were enrolled into the study
  • Subjects with hypersensitivity to Levemir® or any of its excipients

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
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions (SADRs)
Time Frame: during treatment
during treatment
Major hypoglycaemic events
Time Frame: during treatment
during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events
Time Frame: during treatment
during treatment
Number of all adverse events
Time Frame: during treatment
during treatment
Number of all hypoglycaemic events
Time Frame: the last 4 weeks of treatment
the last 4 weeks of treatment
Weight changes
Time Frame: after 12 weeks
after 12 weeks
HbA1c
Time Frame: after 12 weeks and 26 weeks of treatment
after 12 weeks and 26 weeks of treatment
Variability in fasting blood glucose (FBG) and average plasma glucose level
Time Frame: after 12 weeks
after 12 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)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 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

  • NN304-3528

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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