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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
Date last updated
19/09/2024

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
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
Secondary ID [1] 0 0
U1111-1227-8654
Secondary ID [2] 0 0
NN5401-4525
Universal Trial Number (UTN)
Trial acronym
ARISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of study (week 26-36)
Secondary outcome [1] 0 0
HbA1c less than 7% (Yes/No)
Timepoint [1] 0 0
At the end of study (week 26-36)
Secondary outcome [2] 0 0
HbA1c less than pre-defined individual treatment target (Yes/No)
Timepoint [2] 0 0
At the end of study (week 26-36)
Secondary outcome [3] 0 0
Change in local laboratory measured fasting plasma glucose (FPG)
Timepoint [3] 0 0
From baseline (week 0) to end of study (week 26-36)
Secondary outcome [4] 0 0
Change in local laboratory measured FPG
Timepoint [4] 0 0
From baseline (week 0) to end of study (week 26-36)
Secondary outcome [5] 0 0
Change in insulin dose (total, basal, prandial)
Timepoint [5] 0 0
From baseline (week 0) to end of study (week 26-36)
Secondary outcome [6] 0 0
Change in body weight
Timepoint [6] 0 0
From baseline (week 0) to end of study (week 26-36)
Secondary outcome [7] 0 0
Number of patient recollection of non-severe hypoglycaemic episodes
Timepoint [7] 0 0
At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Secondary outcome [8] 0 0
Number of patient recollection of non-severe hypoglycaemic episodes
Timepoint [8] 0 0
At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Secondary outcome [9] 0 0
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Timepoint [9] 0 0
At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Secondary outcome [10] 0 0
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Timepoint [10] 0 0
At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Secondary outcome [11] 0 0
Number of patient recollection of overall severe hypoglycaemic episodes
Timepoint [11] 0 0
At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
Secondary outcome [12] 0 0
Number of patient recollection of overall severe hypoglycaemic episodes
Timepoint [12] 0 0
At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
Secondary outcome [13] 0 0
Number of weekly self-measured plasma glucose (SMPG) measurements
Timepoint [13] 0 0
At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
Secondary outcome [14] 0 0
Number of weekly self-measured plasma glucose (SMPG) measurements
Timepoint [14] 0 0
At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Secondary outcome [15] 0 0
Reason for initiating Ryzodeg® (pre-specified response option(s))
Timepoint [15] 0 0
At baseline (week 0)
Secondary outcome [16] 0 0
Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
Timepoint [16] 0 0
At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Secondary outcome [17] 0 0
Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
Timepoint [17] 0 0
At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Secondary outcome [18] 0 0
Time period from initiation to discontinuation of treatment with Ryzodeg®
Timepoint [18] 0 0
At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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®.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2020
Sample size
Target
Accrual to date
Final
1122
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Elizabeth Vale
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Hobart
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Cooloongup
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
5035 - Keswick
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
6168 - Cooloongup
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Assam
Country [2] 0 0
India
State/province [2] 0 0
Karnataka
Country [3] 0 0
India
State/province [3] 0 0
Maharashtra
Country [4] 0 0
India
State/province [4] 0 0
New Delhi
Country [5] 0 0
India
State/province [5] 0 0
Orissa
Country [6] 0 0
India
State/province [6] 0 0
Punjab
Country [7] 0 0
India
State/province [7] 0 0
Tamil Nadu
Country [8] 0 0
India
State/province [8] 0 0
West Bengal
Country [9] 0 0
Malaysia
State/province [9] 0 0
Kedah
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kelantan
Country [11] 0 0
Malaysia
State/province [11] 0 0
Kota Bharu, Kelantan
Country [12] 0 0
Malaysia
State/province [12] 0 0
Kuala Lumpur
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kuching
Country [14] 0 0
Malaysia
State/province [14] 0 0
Melaka
Country [15] 0 0
Malaysia
State/province [15] 0 0
Penang
Country [16] 0 0
Malaysia
State/province [16] 0 0
Perak
Country [17] 0 0
Malaysia
State/province [17] 0 0
Perlis
Country [18] 0 0
Malaysia
State/province [18] 0 0
Putrajaya
Country [19] 0 0
Malaysia
State/province [19] 0 0
Selangor
Country [20] 0 0
Philippines
State/province [20] 0 0
Aklan
Country [21] 0 0
Philippines
State/province [21] 0 0
Cebu City
Country [22] 0 0
Philippines
State/province [22] 0 0
Davao City
Country [23] 0 0
Philippines
State/province [23] 0 0
Iloilo
Country [24] 0 0
Philippines
State/province [24] 0 0
Makati City
Country [25] 0 0
Philippines
State/province [25] 0 0
Manila
Country [26] 0 0
Philippines
State/province [26] 0 0
Quezon City
Country [27] 0 0
Saudi Arabia
State/province [27] 0 0
Jeddah
Country [28] 0 0
Saudi Arabia
State/province [28] 0 0
Makkah
Country [29] 0 0
Saudi Arabia
State/province [29] 0 0
Riyadh
Country [30] 0 0
South Africa
State/province [30] 0 0
Eastern Cape
Country [31] 0 0
South Africa
State/province [31] 0 0
Gauteng
Country [32] 0 0
South Africa
State/province [32] 0 0
KwaZulu-Natal
Country [33] 0 0
South Africa
State/province [33] 0 0
Alberton
Country [34] 0 0
South Africa
State/province [34] 0 0
Bloemfontein

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04042441
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04042441