Clinical trial NCT04042441: A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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®.

Primary outcomes:
measure: Change in local laboratory measured glycosylated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of study (week 26-36)
Secondary outcomes:
measure: HbA1c less than 7% (Yes/No)
timeFrame: At the end of study (week 26-36)
measure: HbA1c less than pre-defined individual treatment target (Yes/No)
timeFrame: At the end of study (week 26-36)
measure: Change in local laboratory measured fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of study (week 26-36)
measure: Change in local laboratory measured FPG
timeFrame: From baseline (week 0) to end of study (week 26-36)
measure: Change in insulin dose (total, basal, prandial)
timeFrame: From baseline (week 0) to end of study (week 26-36)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of study (week 26-36)
measure: Number of patient recollection of non-severe hypoglycaemic episodes
timeFrame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
measure: Number of patient recollection of non-severe hypoglycaemic episodes
timeFrame: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
measure: Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
timeFrame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
measure: Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
timeFrame: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
measure: Number of patient recollection of overall severe hypoglycaemic episodes
timeFrame: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
measure: Number of patient recollection of overall severe hypoglycaemic episodes
timeFrame: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
measure: Number of weekly self-measured plasma glucose (SMPG) measurements
timeFrame: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
measure: Number of weekly self-measured plasma glucose (SMPG) measurements
timeFrame: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
measure: Reason for initiating Ryzodeg® (pre-specified response option(s))
timeFrame: At baseline (week 0)
measure: Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
timeFrame: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
measure: Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
timeFrame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
measure: Time period from initiation to discontinuation of treatment with Ryzodeg®
timeFrame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Diabetes Service Clinical Trials & Research Unit
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Keswick
country: Australia
facility: South Australian Endocrine Research
state: South Australia
city: Hobart
country: Australia
facility: Hobart Cardiology
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Specialist Consulting rooms
state: Victoria
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute
state: Victoria
city: Cooloongup
country: Australia
facility: Rockingham General Hospital
state: Western Australia
city: Guwahati
country: India
facility: Excelcare Hospital
state: Assam
city: Bangalore
country: India
facility: Columbia Asia Hospital
state: Karnataka
city: Bangalore
country: India
facility: Pace Diabetes Center
state: Karnataka
city: Nagpur
country: India
facility: DEW Medicare & Trinity hospital
state: Maharashtra
city: Delhi
country: India
facility: Max Super Speciality Shalimar Bhagh
state: New Delhi
city: Bhubaneswar
country: India
facility: AMRI Hospital
state: Orissa
city: Mohali
country: India
facility: Fortis Heart Institute and Multispeciality Hospital
state: Punjab
city: Chennai
country: India
facility: R.M. Diabetes Education & Research Foundation
state: Tamil Nadu
city: Howrah
country: India
facility: Narayana Superspeciality Hospital
state: West Bengal
city: New Delhi
country: India
facility: Fortis Hospital
city: Kedah
country: Malaysia
facility: Pantai Hospital
city: Kelantan
country: Malaysia
facility: Kota Bahru Medical Centre Sdn Bhd
city: Kota Bharu, Kelantan
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Kuala Lumpur
country: Malaysia
facility: Gleneagles Hospital
city: Kuching
country: Malaysia
facility: Borneo Medical Centre
city: Kuching
country: Malaysia
facility: KPJ Kuching
city: Melaka
country: Malaysia
facility: Mahkota Medical Center
city: Melaka
country: Malaysia
facility: Pantai Hospital Ayer Keroh
city: Penang
country: Malaysia
facility: Island Hospital
city: Perak
country: Malaysia
facility: Klinik Chong
city: Perlis
country: Malaysia
facility: Remedic Clinic
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya
city: Selangor
country: Malaysia
facility: Subang Jaya Medical Center
city: Selangor
country: Malaysia
facility: Thomson Hospital
city: Aklan
country: Philippines
facility: Panay Healthcare Medical Center
city: Cebu City
country: Philippines
facility: Perpetual Succor Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo
country: Philippines
facility: Iloilo Diabetes Care Center
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas
city: Manila
country: Philippines
facility: Manila Doctor's Hospital
city: Manila
country: Philippines
facility: University of Sto. Tomas Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Quezon City
country: Philippines
facility: Providence Hospital
city: Quezon City
country: Philippines
facility: University of the East-Ramon Magsaysay Memorial Medical Ctr
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
city: Jeddah
country: Saudi Arabia
facility: Dr Bakhsh Hospital
city: Jeddah
country: Saudi Arabia
facility: Dr. Ghassan N. Faroun Hospital
city: Jeddah
country: Saudi Arabia
facility: Saudi German Hospital
city: Jeddah
country: Saudi Arabia
facility: My clinic
city: Makkah
country: Saudi Arabia
facility: Umm Alquara University Hospital
city: Riyadh
country: Saudi Arabia
facility: Specialized medical center
city: Riyadh
country: Saudi Arabia
facility: Riyadh Care Hospital
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: Dallah Hospital
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Netcare Greenacres Hospital
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: ProHealth Wellness Centre
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Lenasia
country: South Africa
facility: Dr Moosa's Rooms
state: Gauteng
city: Pretoria
country: South Africa
facility: Prof P. Joshi
state: Gauteng
city: Berea
country: South Africa
facility: Dr H Bacus
state: KwaZulu-Natal
city: Alberton
country: South Africa
facility: Union Hospital
city: Bloemfontein
country: South Africa
facility: Medi-Clinic Bloemfontein
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Fulcher GR, Cohen ND, Davies K, d'Emden M, Glastras SJ, Mah PM, McCallum RW, Moses R, Thong KY, Roberts A. Initiating or switching to insulin degludec/insulin aspart in a real-world population of adults with type 2 diabetes in Australia: results from a prospective, non-interventional study. Intern Med J. 2024 Oct;54(10):1626-1633. doi: 10.1111/imj.16492. Epub 2024 Aug 22.
citation: 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.
citation: 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.