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

January 30, 2017 updated by: Novo Nordisk A/S

A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent 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 Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51170

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

  • Belgium
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Prague, Czech Republic, 16000
        • Novo Nordisk Investigational Site
  • Denmark
      • Copenhagen S, Denmark, 2300
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, FI-02600
        • Novo Nordisk Investigational Site
  • France
      • Paris La défense cedex, France, 92932
        • Novo Nordisk Investigational Site
  • Greece
      • Vouliagment, Greece, 16671
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin 2, Ireland
        • Novo Nordisk Investigational Site
  • Israel
      • Kfar Saba, Israel, 44425
        • Novo Nordisk Investigational Site
  • Italy
      • Rome, Italy, 00144
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-920
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 202 15
        • Novo Nordisk Investigational Site
  • Turkey
      • Istanbul, Turkey, 34335
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Crawley, United Kingdom, RH11 9RT
        • 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 who have been deemed appropriate to receive Levemir® (insulin detemir) as new treatment and as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Age according to approved label in each country and physician discretion
  • Type 1 or 2 diabetes
  • Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin
  • Selection at the discretion of the physician

Exclusion Criteria:

  • Current treatment with Levemir® (insulin detemir)
  • Previously enrolled in the study
  • Hypersensitivity to Levemir® (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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
Type 2 diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
Time Frame: Months 0-12
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.
Months 0-12

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.

General Publications

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

June 1, 2004

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1677

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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