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Completed

NCT Number: NCT01545791

Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Dublin, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician

Primary outcomes

  1. Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events

    Time frame: Weeks 0-26

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: PREDICTIVE™

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2012
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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