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

Diabetes Mellitus, Type 2 Clinical Trial

— ARISE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042441
• Other study ID #: NN5401-4525
• Secondary ID: U1111-1227-8654
• Status: Completed
• Start date: July 29, 2019
• Est. completion date: December 11, 2020

Study information

• Verified date: February 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1122
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Box Hill	Victoria
Australia	Novo Nordisk Investigational Site	Cooloongup	Western Australia
Australia	Novo Nordisk Investigational Site	Elizabeth Vale	South Australia
Australia	Novo Nordisk Investigational Site	Herston	Queensland
Australia	Novo Nordisk Investigational Site	Hobart	Tasmania
Australia	Novo Nordisk Investigational Site	Keswick	South Australia
Australia	Novo Nordisk Investigational Site	Melbourne	Victoria
Australia	Novo Nordisk Investigational Site	South Brisbane	Queensland
Australia	Novo Nordisk Investigational Site	St Leonards	New South Wales
Australia	Novo Nordisk Investigational Site	Wollongong	New South Wales
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bhubaneswar	Orissa
India	Novo Nordisk Investigational Site	Chennai	Tamil Nadu
India	Novo Nordisk Investigational Site	Delhi	New Delhi
India	Novo Nordisk Investigational Site	Guwahati	Assam
India	Novo Nordisk Investigational Site	Howrah	West Bengal
India	Novo Nordisk Investigational Site	Mohali	Punjab
India	Novo Nordisk Investigational Site	Nagpur	Maharashtra
India	Novo Nordisk Investigational Site	New Delhi
Malaysia	Novo Nordisk Investigational Site	Kedah
Malaysia	Novo Nordisk Investigational Site	Kelantan
Malaysia	Novo Nordisk Investigational Site	Kota Bharu, Kelantan
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Malaysia	Novo Nordisk Investigational Site	Kuching
Malaysia	Novo Nordisk Investigational Site	Melaka
Malaysia	Novo Nordisk Investigational Site	Melaka
Malaysia	Novo Nordisk Investigational Site	Penang
Malaysia	Novo Nordisk Investigational Site	Perak
Malaysia	Novo Nordisk Investigational Site	Perlis
Malaysia	Novo Nordisk Investigational Site	Putrajaya
Malaysia	Novo Nordisk Investigational Site	Selangor
Malaysia	Novo Nordisk Investigational Site	Selangor
Philippines	Novo Nordisk Investigational Site	Aklan
Philippines	Novo Nordisk Investigational Site	Cebu City
Philippines	Novo Nordisk Investigational Site	Davao City
Philippines	Novo Nordisk Investigational Site	Iloilo
Philippines	Novo Nordisk Investigational Site	Makati City
Philippines	Novo Nordisk Investigational Site	Manila
Philippines	Novo Nordisk Investigational Site	Manila
Philippines	Novo Nordisk Investigational Site	Quezon City
Philippines	Novo Nordisk Investigational Site	Quezon City
Saudi Arabia	Novo Nordisk Investigational Site	Jeddah
Saudi Arabia	Novo Nordisk Investigational Site	Jeddah
Saudi Arabia	Novo Nordisk Investigational Site	Jeddah
Saudi Arabia	Novo Nordisk Investigational Site	Jeddah
Saudi Arabia	Novo Nordisk Investigational Site	Makkah
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
South Africa	Novo Nordisk Investigational Site	Alberton
South Africa	Novo Nordisk Investigational Site	Berea	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Bloemfontein
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Lenasia	Gauteng
South Africa	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape
South Africa	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  India,  Malaysia,  Philippines,  Saudi Arabia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in local laboratory measured glycosylated haemoglobin (HbA1c)	Percentage point	From baseline (week 0) to end of study (week 26-36)
Secondary	HbA1c less than 7% (Yes/No)	Percentage of patients	At the end of study (week 26-36)
Secondary	HbA1c less than pre-defined individual treatment target (Yes/No)	Percentage of patients	At the end of study (week 26-36)
Secondary	Change in local laboratory measured fasting plasma glucose (FPG)	mg/dL	From baseline (week 0) to end of study (week 26-36)
Secondary	Change in local laboratory measured FPG	mmol/L	From baseline (week 0) to end of study (week 26-36)
Secondary	Change in insulin dose (total, basal, prandial)	units/day	From baseline (week 0) to end of study (week 26-36)
Secondary	Change in body weight	Kg	From baseline (week 0) to end of study (week 26-36)
Secondary	Number of patient recollection of non-severe hypoglycaemic episodes	Number of episodes	At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Secondary	Number of patient recollection of non-severe hypoglycaemic episodes	Number of episodes	At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Secondary	Number of patient recollection of nocturnal non-severe hypoglycaemic episodes	Number of episodes	At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Secondary	Number of patient recollection of nocturnal non-severe hypoglycaemic episodes	Number of episodes	At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Secondary	Number of patient recollection of overall severe hypoglycaemic episodes	Number of episodes	At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
Secondary	Number of patient recollection of overall severe hypoglycaemic episodes	Number of episodes	At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
Secondary	Number of weekly self-measured plasma glucose (SMPG) measurements	Number of measurements	At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
Secondary	Number of weekly self-measured plasma glucose (SMPG) measurements	Number of measurements	At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Secondary	Reason for initiating Ryzodeg® (pre-specified response option(s))	Percentage of patients per response option	At baseline (week 0)
Secondary	Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)	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
Secondary	Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))	Percentage of patients per response option	At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Secondary	Time period from initiation to discontinuation of treatment with Ryzodeg®	Days	At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation