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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01545791
First received: March 1, 2012
Last updated: March 6, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of serious adverse events (SAEs) [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
  • Number of all adverse events (AEs) [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
  • Number of all hypoglycaemic events [ Time Frame: In the 4 weeks preceeding week 26 ] [ Designated as safety issue: No ]
  • Weight change [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Variability in fasting plasma glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Average plasma glucose level [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Quality of Life as assessed by a treatment satisfaction questionnaire [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545791

Locations
Ireland
Dublin, Ireland, DUBLIN 15
United Kingdom
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jenna Copeland Novo Nordisk A/S
Study Director: Senthil Vel Novo Nordisk Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01545791     History of Changes
Other Study ID Numbers: NN304-1952
Study First Received: March 1, 2012
Last Updated: March 6, 2012
Health Authority: Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014