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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545791
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

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

Study Design

Study Type : Observational
Actual Enrollment : 1037 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2006
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events [ Time Frame: Weeks 0-26 ]

Secondary Outcome Measures :
  1. Number of serious adverse events (SAEs) [ Time Frame: Weeks 0-26 ]
  2. Number of all adverse events (AEs) [ Time Frame: Weeks 0-26 ]
  3. Number of all hypoglycaemic events [ Time Frame: In the 4 weeks preceeding week 26 ]
  4. Weight change [ Time Frame: Week 0, week 26 ]
  5. Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 26 ]
  6. Variability in fasting plasma glucose (FPG) [ Time Frame: Week 26 ]
  7. Average plasma glucose level [ Time Frame: Week 26 ]
  8. Quality of Life as assessed by a treatment satisfaction questionnaire [ Time Frame: Week 26 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 110 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations

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): NCT01545791


Locations
Ireland
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 15
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01545791     History of Changes
Other Study ID Numbers: NN304-1952
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

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