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OpenTrials
Completed

NCT Number: NCT04042441

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

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 them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal North Shore Hospital, St Leonards, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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®.

Treatment and study plan

insulin degludec/insulin aspart

Drug

Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.

Primary outcomes

  1. Change in local laboratory measured glycosylated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of study (week 26-36)

    Percentage point

Secondary outcomes

  1. HbA1c less than 7% (Yes/No)

    Time frame: At the end of study (week 26-36)

    Percentage of patients

  2. HbA1c less than pre-defined individual treatment target (Yes/No)

    Time frame: At the end of study (week 26-36)

    Percentage of patients

  3. Change in local laboratory measured fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to end of study (week 26-36)

    mg/dL

  4. Change in local laboratory measured FPG

    Time frame: From baseline (week 0) to end of study (week 26-36)

    mmol/L

  5. Change in insulin dose (total, basal, prandial)

    Time frame: From baseline (week 0) to end of study (week 26-36)

    units/day

  6. Change in body weight

    Time frame: From baseline (week 0) to end of study (week 26-36)

    Kg

  7. Number of patient recollection of non-severe hypoglycaemic episodes

    Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®

    Number of episodes

  8. Number of patient recollection of non-severe hypoglycaemic episodes

    Time frame: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study

    Number of episodes

  9. Number of patient recollection of nocturnal non-severe hypoglycaemic episodes

    Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®

    Number of episodes

  10. Number of patient recollection of nocturnal non-severe hypoglycaemic episodes

    Time frame: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study

    Number of episodes

  11. Number of patient recollection of overall severe hypoglycaemic episodes

    Time frame: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®

    Number of episodes

  12. Number of patient recollection of overall severe hypoglycaemic episodes

    Time frame: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study

    Number of episodes

  13. Number of weekly self-measured plasma glucose (SMPG) measurements

    Time frame: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®

    Number of measurements

  14. Number of weekly self-measured plasma glucose (SMPG) measurements

    Time frame: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study

    Number of measurements

  15. Reason for initiating Ryzodeg® (pre-specified response option(s))

    Time frame: At baseline (week 0)

    Percentage of patients per response option

  16. Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)

    Time frame: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

    Percentage of patients

  17. Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))

    Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

    Percentage of patients per response option

  18. Time period from initiation to discontinuation of treatment with Ryzodeg®

    Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

    Days

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting

Acronym: ARISE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Sep 19, 2024

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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