Status:

COMPLETED

A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to the...

Eligibility Criteria

Inclusion

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
  • The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study.
  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.
  • Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.

Exclusion

  • Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Previous treatment with Ryzodeg®.

Key Trial Info

Start Date :

July 29 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 11 2020

Estimated Enrollment :

1122 Patients enrolled

Trial Details

Trial ID

NCT04042441

Start Date

July 29 2019

End Date

December 11 2020

Last Update

September 19 2024

Active Locations (64)

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Page 1 of 16 (64 locations)

1

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

2

Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, Australia, 2500

3

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4029

4

Mater Hospital Brisbane

South Brisbane, Queensland, Australia, 4101