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

February 18, 2021 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Novo Nordisk INvestigational Site
      • Wollongong, New South Wales, Australia, 2500
        • Novo Nordisk INvestigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novo Nordisk INvestigational Site
      • South Brisbane, Queensland, Australia, 4101
        • Novo Nordisk INvestigational Site
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Novo Nordisk INvestigational Site
      • Keswick, South Australia, Australia, 5035
        • Novo Nordisk INvestigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Novo Nordisk INvestigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novo Nordisk INvestigational Site
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk INvestigational Site
    • Western Australia
      • Cooloongup, Western Australia, Australia, 6168
        • Novo Nordisk INvestigational Site
  • India
      • New Delhi, India, 110088
        • Novo Nordisk INvestigational Site
    • Assam
      • Guwahati, Assam, India, 781033
        • Novo Nordisk INvestigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Novo Nordisk INvestigational Site
      • Bangalore, Karnataka, India, 560024
        • Novo Nordisk INvestigational Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440015
        • Novo Nordisk INvestigational Site
    • New Delhi
      • Delhi, New Delhi, India, 110088
        • Novo Nordisk INvestigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751030
        • Novo Nordisk INvestigational Site
    • Punjab
      • Mohali, Punjab, India, 160062
        • Novo Nordisk INvestigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600040
        • Novo Nordisk INvestigational Site
    • West Bengal
      • Howrah, West Bengal, India, 711103
        • Novo Nordisk INvestigational Site
  • Malaysia
      • Kedah, Malaysia, 08000
        • Novo Nordisk INvestigational Site
      • Kelantan, Malaysia, 15200
        • Novo Nordisk INvestigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk INvestigational Site
      • Kuala Lumpur, Malaysia, 50450
        • Novo Nordisk INvestigational Site
      • Kuching, Malaysia, 93350
        • Novo Nordisk INvestigational Site
      • Melaka, Malaysia, 75000
        • Novo Nordisk INvestigational Site
      • Melaka, Malaysia, 75450
        • Novo Nordisk INvestigational Site
      • Penang, Malaysia, 10450
        • Novo Nordisk INvestigational Site
      • Perak, Malaysia, 35800
        • Novo Nordisk INvestigational Site
      • Perlis, Malaysia, 01000
        • Novo Nordisk INvestigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk INvestigational Site
      • Selangor, Malaysia, 47500
        • Novo Nordisk INvestigational Site
      • Selangor, Malaysia, 47810
        • Novo Nordisk INvestigational Site
  • Philippines
      • Aklan, Philippines
        • Novo Nordisk INvestigational Site
      • Cebu City, Philippines
        • Novo Nordisk INvestigational Site
      • Davao City, Philippines, 8000
        • Novo Nordisk INvestigational Site
      • Iloilo, Philippines, 5000
        • Novo Nordisk INvestigational Site
      • Makati City, Philippines, 1229
        • Novo Nordisk INvestigational Site
      • Manila, Philippines
        • Novo Nordisk INvestigational Site
      • Manila, Philippines, 1015
        • Novo Nordisk INvestigational Site
      • Quezon City, Philippines, 1102
        • Novo Nordisk INvestigational Site
      • Quezon City, Philippines
        • Novo Nordisk INvestigational Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 22252
        • Novo Nordisk INvestigational Site
      • Jeddah, Saudi Arabia, 23216
        • Novo Nordisk INvestigational Site
      • Jeddah, Saudi Arabia, 23521
        • Novo Nordisk INvestigational Site
      • Jeddah, Saudi Arabia
        • Novo Nordisk INvestigational Site
      • Makkah, Saudi Arabia, 24381
        • Novo Nordisk INvestigational Site
      • Riyadh, Saudi Arabia, 12311
        • Novo Nordisk INvestigational Site
      • Riyadh, Saudi Arabia, 14214
        • Novo Nordisk INvestigational Site
      • Riyadh, Saudi Arabia, 14611
        • Novo Nordisk INvestigational Site
      • Riyadh, Saudi Arabia, 14963
        • Novo Nordisk INvestigational Site
  • South Africa
      • Alberton, South Africa, 1449
        • Novo Nordisk INvestigational Site
      • Bloemfontein, South Africa, 9301
        • Novo Nordisk INvestigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk INvestigational Site
      • Port Elizabeth, Eastern Cape, South Africa, 6201
        • Novo Nordisk INvestigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk INvestigational Site
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk INvestigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk INvestigational Site
    • KwaZulu-Natal
      • Berea, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Real-world population of type 2 patients, who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice

Description

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®.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ryzodeg® as per local practice
Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice.
Drug: Insulin Degludec/Insulin Aspart
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of study (week 26-36)
Percentage point
From baseline (week 0) to end of study (week 26-36)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c less than 7% (Yes/No)
Time Frame: At the end of study (week 26-36)
Percentage of patients
At the end of study (week 26-36)
HbA1c less than pre-defined individual treatment target (Yes/No)
Time Frame: At the end of study (week 26-36)
Percentage of patients
At the end of study (week 26-36)
Change in local laboratory measured fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to end of study (week 26-36)
mg/dL
From baseline (week 0) to end of study (week 26-36)
Change in local laboratory measured FPG
Time Frame: From baseline (week 0) to end of study (week 26-36)
mmol/L
From baseline (week 0) to end of study (week 26-36)
Change in insulin dose (total, basal, prandial)
Time Frame: From baseline (week 0) to end of study (week 26-36)
units/day
From baseline (week 0) to end of study (week 26-36)
Change in body weight
Time Frame: From baseline (week 0) to end of study (week 26-36)
Kg
From baseline (week 0) to end of study (week 26-36)
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
At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
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
At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
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
At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
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
At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
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
At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
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
At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
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
At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
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
At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Reason for initiating Ryzodeg® (pre-specified response option(s))
Time Frame: At baseline (week 0)
Percentage of patients per response option
At baseline (week 0)
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
At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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
At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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
At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2019

Primary Completion (ACTUAL)

December 11, 2020

Study Completion (ACTUAL)

December 11, 2020

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (ACTUAL)

August 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4525
  • U1111-1227-8654 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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