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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545791
First Posted: March 7, 2012
Last Update Posted: October 28, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

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

Enrollment: 1037
Study Start Date: May 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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 Submitted: March 1, 2012
First Posted: March 7, 2012
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