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OpenTrials
Completed

NCT Number: NCT01984372

Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®

This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment

Exclusion criteria

  • Patients who are or have previously been on Tresiba® therapy
  • Patients who have previously been participating in this PMS

Treatment and study plan

insulin degludec

Drug

Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.

Primary outcomes

  1. Incidence of AEs (Adverse Events) by preferred term

    Time frame: During 3 years of treatment

Secondary outcomes

  1. Incidence of AEs (Adverse Events) by preferred term

    Time frame: During 6 months of treatment

  2. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term

    Time frame: During 6 months of treatment

  3. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term

    Time frame: During 3 years of treatment

  4. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term

    Time frame: During 6 months of treatment

  5. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term

    Time frame: During 3 years of treatment

  6. Incidence of severe hypoglycaemia

    Time frame: During 6 months of treatment

  7. Incidence of severe hypoglycaemia

    Time frame: During 3 years of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2013
Registry last updated
Aug 4, 2020

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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