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

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

A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Through Intensification and Control to Target: An International Variability Evaluation

This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1037

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

  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, W12 OHS
        • 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

No older than 110 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient with type 1 or type 2 diabetes mellitus was eligible for the study, including newly diagnosed patients who had never received insulin or an insulin analogue before

Description

Inclusion Criteria:

  • Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before

Exclusion Criteria:

  • Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
  • Patients previously enrolled in this study
  • Patients with a hypersensitivity to insulin detemir

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
Insulin detemir users
Drug: insulin detemir
Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events
Time Frame: Weeks 0-26
Weeks 0-26

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events (SAEs)
Time Frame: Weeks 0-26
Weeks 0-26
Number of all adverse events (AEs)
Time Frame: Weeks 0-26
Weeks 0-26
Number of all hypoglycaemic events
Time Frame: In the 4 weeks preceeding week 26
In the 4 weeks preceeding week 26
Weight change
Time Frame: Week 0, week 26
Week 0, week 26
Glycosylated haemoglobin (HbA1c)
Time Frame: Week 26
Week 26
Variability in fasting plasma glucose (FPG)
Time Frame: Week 26
Week 26
Average plasma glucose level
Time Frame: Week 26
Week 26
Quality of Life as assessed by a treatment satisfaction questionnaire
Time Frame: Week 26
Week 26

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

May 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

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

  • NN304-1952

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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