Observational Study to Evaluate the Safety of Levemir® in Diabetes (PREDICTIVE™)

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 observational study is conducted in North America. 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)

2282

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

  • Mexico
      • Mexico City, Mexico
        • 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

Patients from both general and speciality practice settings deemed appropraite to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician

Description

Inclusion Criteria:

  • Type 1 or 2 diabetes
  • Including newly diagnosed not on insulin or insulin analogue treatment
  • Selection at the discretion of the physician
  • Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion Criteria:

  • Current treatment with Levemir®
  • Previously enrolled in the study
  • Hypersensitivity to Levemir®

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: Cohort
  • Time Perspectives: Prospective

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
Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)
Time Frame: during treatment
during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose control measures
Time Frame: during treatment
during treatment
Weight
Time Frame: during treatment
during treatment

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

September 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (Estimate)

June 27, 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

  • NN304-3518

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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