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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04042441
Registration number
NCT04042441
Ethics application status
Date submitted
31/07/2019
Date registered
2/08/2019
Titles & IDs
Public title
A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
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Scientific 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
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Secondary ID [1]
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U1111-1227-8654
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Secondary ID [2]
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NN5401-4525
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Universal Trial Number (UTN)
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Trial acronym
ARISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin Degludec/Insulin Aspart
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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in local laboratory measured glycosylated haemoglobin (HbA1c)
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Assessment method [1]
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Percentage point
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Timepoint [1]
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From baseline (week 0) to end of study (week 26-36)
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Secondary outcome [1]
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HbA1c less than 7% (Yes/No)
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Assessment method [1]
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Percentage of patients
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Timepoint [1]
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At the end of study (week 26-36)
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Secondary outcome [2]
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HbA1c less than pre-defined individual treatment target (Yes/No)
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Assessment method [2]
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Percentage of patients
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Timepoint [2]
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At the end of study (week 26-36)
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Secondary outcome [3]
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Change in local laboratory measured fasting plasma glucose (FPG)
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Assessment method [3]
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mg/dL
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Timepoint [3]
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From baseline (week 0) to end of study (week 26-36)
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Secondary outcome [4]
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Change in local laboratory measured FPG
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Assessment method [4]
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mmol/L
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Timepoint [4]
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From baseline (week 0) to end of study (week 26-36)
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Secondary outcome [5]
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Change in insulin dose (total, basal, prandial)
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Assessment method [5]
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units/day
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Timepoint [5]
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From baseline (week 0) to end of study (week 26-36)
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Secondary outcome [6]
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Change in body weight
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Assessment method [6]
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Kg
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Timepoint [6]
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From baseline (week 0) to end of study (week 26-36)
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Secondary outcome [7]
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Number of patient recollection of non-severe hypoglycaemic episodes
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Assessment method [7]
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Number of episodes
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Timepoint [7]
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At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
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Secondary outcome [8]
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Number of patient recollection of non-severe hypoglycaemic episodes
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Assessment method [8]
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Number of episodes
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Timepoint [8]
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At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
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Secondary outcome [9]
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Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
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Assessment method [9]
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Number of episodes
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Timepoint [9]
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At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
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Secondary outcome [10]
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Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
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Assessment method [10]
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Number of episodes
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Timepoint [10]
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At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
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Secondary outcome [11]
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Number of patient recollection of overall severe hypoglycaemic episodes
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Assessment method [11]
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Number of episodes
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Timepoint [11]
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At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
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Secondary outcome [12]
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Number of patient recollection of overall severe hypoglycaemic episodes
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Assessment method [12]
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Number of episodes
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Timepoint [12]
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At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
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Secondary outcome [13]
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Number of weekly self-measured plasma glucose (SMPG) measurements
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Assessment method [13]
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Number of measurements
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Timepoint [13]
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At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
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Secondary outcome [14]
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Number of weekly self-measured plasma glucose (SMPG) measurements
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Assessment method [14]
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Number of measurements
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Timepoint [14]
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At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
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Secondary outcome [15]
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Reason for initiating Ryzodeg® (pre-specified response option(s))
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Assessment method [15]
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Percentage of patients per response option
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Timepoint [15]
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At baseline (week 0)
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Secondary outcome [16]
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Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
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Assessment method [16]
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Percentage of patients
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Timepoint [16]
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At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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Secondary outcome [17]
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Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
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Assessment method [17]
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Percentage of patients per response option
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Timepoint [17]
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At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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Secondary outcome [18]
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Time period from initiation to discontinuation of treatment with Ryzodeg®
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Assessment method [18]
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Days
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Timepoint [18]
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At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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®.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/12/2020
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Sample size
Target
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Accrual to date
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Final
1122
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - St Leonards
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Wollongong
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Herston
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - South Brisbane
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Elizabeth Vale
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Recruitment hospital [6]
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Novo Nordisk Investigational Site - Keswick
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Recruitment hospital [7]
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Novo Nordisk Investigational Site - Hobart
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Recruitment hospital [8]
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Novo Nordisk Investigational Site - Box Hill
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Recruitment hospital [9]
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Novo Nordisk Investigational Site - Melbourne
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Recruitment hospital [10]
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Novo Nordisk Investigational Site - Cooloongup
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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5035 - Keswick
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Recruitment postcode(s) [7]
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7000 - Hobart
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3004 - Melbourne
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Recruitment postcode(s) [10]
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6168 - Cooloongup
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Assam
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Country [2]
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India
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State/province [2]
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Karnataka
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Country [3]
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India
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State/province [3]
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Maharashtra
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Country [4]
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India
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State/province [4]
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New Delhi
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Country [5]
0
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India
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State/province [5]
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Orissa
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Country [6]
0
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India
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State/province [6]
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Punjab
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Country [7]
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India
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State/province [7]
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Tamil Nadu
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Country [8]
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India
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State/province [8]
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West Bengal
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Country [9]
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Malaysia
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State/province [9]
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Kedah
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Country [10]
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Malaysia
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State/province [10]
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Kelantan
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Country [11]
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Malaysia
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State/province [11]
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Kota Bharu, Kelantan
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Country [12]
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Malaysia
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State/province [12]
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Kuala Lumpur
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Country [13]
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Malaysia
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State/province [13]
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Kuching
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Country [14]
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Malaysia
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State/province [14]
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Melaka
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Country [15]
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Malaysia
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State/province [15]
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Penang
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Country [16]
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Malaysia
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State/province [16]
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Perak
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Country [17]
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Malaysia
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State/province [17]
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Perlis
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Country [18]
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Malaysia
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State/province [18]
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Putrajaya
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Country [19]
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Malaysia
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State/province [19]
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Selangor
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Country [20]
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Philippines
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State/province [20]
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Aklan
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Philippines
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State/province [21]
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Cebu City
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Philippines
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Davao City
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Philippines
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State/province [23]
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Iloilo
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Philippines
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State/province [24]
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Makati City
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Philippines
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State/province [25]
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Manila
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Philippines
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Quezon City
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Country [27]
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Saudi Arabia
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State/province [27]
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Jeddah
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Saudi Arabia
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State/province [28]
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Makkah
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Country [29]
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Saudi Arabia
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State/province [29]
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Riyadh
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Country [30]
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South Africa
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State/province [30]
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Eastern Cape
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Country [31]
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South Africa
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State/province [31]
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Gauteng
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Country [32]
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South Africa
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State/province [32]
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KwaZulu-Natal
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Country [33]
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South Africa
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State/province [33]
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Alberton
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Country [34]
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South Africa
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State/province [34]
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Bloemfontein
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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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Trial website
https://clinicaltrials.gov/study/NCT04042441
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Trial related presentations / publications
Fulcher GR, Akhtar S, Al-Jaser SJ, Medina J, Mohamed M, Nicodemus NA Jr, Olsen AH, Singh KP, Kok A. Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries. Adv Ther. 2022 Aug;39(8):3735-3748. doi: 10.1007/s12325-022-02212-3. Epub 2022 Jun 25. Erratum In: Adv Ther. 2023 Jan;40(1):389-390. doi: 10.1007/s12325-022-02349-1. Fulcher GR, Jarlov H, Piltoft JS, Singh KP, Liu L, Mohamed M, Nicodemus NA Jr, Al-Jaser SJ, Kok A. ARISE-a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design. Endocrine. 2021 Dec;74(3):530-537. doi: 10.1007/s12020-021-02887-8. Epub 2021 Oct 12. Erratum In: Endocrine. 2022 Mar;75(3):964. doi: 10.1007/s12020-021-02956-y.
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Public notes
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Contacts
Principal investigator
Name
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Clinical Reporting Anchor and Disclosure (1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04042441