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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014