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

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ClinicalTrials.gov Identifier: NCT00659295
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : August 16, 2011
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Design
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Study Type : Observational
Actual Enrollment : 51170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659295


Locations
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Czech Republic
Novo Nordisk Investigational Site
Prague, Czech Republic, 16000
Denmark
Novo Nordisk Investigational Site
Copenhagen S, Denmark, 2300
Finland
Novo Nordisk Investigational Site
Espoo, Finland, FI-02600
France
Novo Nordisk Investigational Site
Paris La défense cedex, France, 92932
Greece
Novo Nordisk Investigational Site
Vouliagment, Greece, 16671
Ireland
Novo Nordisk Investigational Site
Dublin 2, Ireland
Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 202 15
Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34335
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00659295     History of Changes
Other Study ID Numbers: NN304-1677
First Posted: April 16, 2008    Key Record Dates
Results First Posted: August 16, 2011
Last Update Posted: March 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs