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Completed

NCT Number: NCT02821052

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

This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders 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

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
  • The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
  • Male or female, no age limitation

Exclusion criteria

  • Patients who are or have previously been treated with Ryzodeg®
  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Patients with a history of hypersensitivity to study product components
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Treatment and study plan

insulin degludec/insulin aspart

Drug

Enrolled patients will be treated with Ryzodeg® under routine clinical practice.

Primary outcomes

  1. Incidence of AEs (adverse event)

    Time frame: Year 0-1

Secondary outcomes

  1. Incidence of SADRs (Serious Adverse Drug Reactions)

    Time frame: Year 0-1

  2. Severe hypoglycaemic episodes

    Time frame: Year 0-1

  3. Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)

    Time frame: Year 0-1

  4. Change in Glycosylated haemoglobin A1c (HbA1c)

    Time frame: Week 0, week 52

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2016
Registry last updated
Oct 15, 2019

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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