Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

November 21, 2023 updated by: Novo Nordisk A/S
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2286

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Type 1 and Type 2 Diabetes

Description

Inclusion Criteria:

  • Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
  • Newly diagnosed insulin naive patients
  • Patients currently on human insulin or on basal insulin
  • Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
  • Usage should be in accordance with the current prescribing information (See attached prescribing information)

Exclusion Criteria:

  • Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
  • Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
  • Pregnant women, those planning to become pregnant, or women who are breastfeeding
  • Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
  • Children below 6 years old

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
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • Levemir™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of Insulin Detemir among Filipino patients
Time Frame: 3 months follow-up visit
3 months follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), 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, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimated)

April 9, 2008

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3525

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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