A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
NCT ID: NCT04042441
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1122 participants
OBSERVATIONAL
2019-07-29
2020-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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®.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
South Australian Endocrine Research
Keswick, South Australia, Australia
Hobart Cardiology
Hobart, Tasmania, Australia
Box Hill Specialist Consulting rooms
Box Hill, Victoria, Australia
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia
Rockingham General Hospital
Cooloongup, Western Australia, Australia
Excelcare Hospital
Guwahati, Assam, India
Columbia Asia Hospital
Bangalore, Karnataka, India
Pace Diabetes Center
Bangalore, Karnataka, India
DEW Medicare & Trinity hospital
Nagpur, Maharashtra, India
Max Super Speciality Shalimar Bhagh
Delhi, New Delhi, India
AMRI Hospital
Bhubaneswar, Odisha, India
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, India
R.M. Diabetes Education & Research Foundation
Chennai, Tamil Nadu, India
Narayana Superspeciality Hospital
Howrah, West Bengal, India
Fortis Hospital
New Delhi, , India
Island Hospital
George Town, , Malaysia
Remedic Clinic
Kangar, , Malaysia
Pantai Hospital
Kedah, , Malaysia
Kota Bahru Medical Centre Sdn Bhd
Kelantan, , Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, , Malaysia
Gleneagles Hospital
Kuala Lumpur, , Malaysia
Subang Jaya Medical Center
Kuala Selangor, , Malaysia
Thomson Hospital
Kuala Selangor, , Malaysia
Borneo Medical Centre
Kuching, , Malaysia
KPJ Kuching
Kuching, , Malaysia
Mahkota Medical Center
Malacca, , Malaysia
Pantai Hospital Ayer Keroh
Malacca, , Malaysia
Klinik Chong
Perak, , Malaysia
Hospital Putrajaya
Putrajaya, , Malaysia
Panay Healthcare Medical Center
Aklan, , Philippines
Perpetual Succor Hospital
Cebu City, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Iloilo Diabetes Care Center
Iloilo City, , Philippines
Makati Medical Center
Makati City, , Philippines
University of Santo Tomas
Manila, , Philippines
Manila Doctor's Hospital
Manila, , Philippines
University of Sto. Tomas Hospital
Manila, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Providence Hospital
Quezon City, , Philippines
University of the East-Ramon Magsaysay Memorial Medical Ctr
Quezon City, , Philippines
King Abdulaziz University Hospital
Jeddah, , Saudi Arabia
Dr Bakhsh Hospital
Jeddah, , Saudi Arabia
Dr. Ghassan N. Faroun Hospital
Jeddah, , Saudi Arabia
Saudi German Hospital
Jeddah, , Saudi Arabia
My clinic
Jeddah, , Saudi Arabia
Umm Alquara University Hospital
Mecca, , Saudi Arabia
Specialized medical center
Riyadh, , Saudi Arabia
Riyadh Care Hospital
Riyadh, , Saudi Arabia
National Guard Hospital
Riyadh, , Saudi Arabia
Dallah Hospital
Riyadh, , Saudi Arabia
Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa
ProHealth Wellness Centre
Port Elizabeth, Eastern Cape, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Dr Moosa's Rooms
Lenasia, Gauteng, South Africa
Prof P. Joshi
Pretoria, Gauteng, South Africa
Dr H Bacus
Berea, KwaZulu-Natal, South Africa
Union Hospital
Alberton, , South Africa
Medi-Clinic Bloemfontein
Bloemfontein, , South Africa
Countries
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References
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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.
Baruah MP, Aneja P, Pitale S, Bhograj A, Agrawala RK, Aggarwal A, Mahadev PG, Madhavdas DC, Shah S, John M, Pathan MKA, Revanna M, Chandrappa M, Singh KP. Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study. J Family Med Prim Care. 2024 Sep;13(9):3590-3597. doi: 10.4103/jfmpc.jfmpc_1401_23. Epub 2024 Sep 11.
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.
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.
Other Identifiers
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U1111-1227-8654
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-4525
Identifier Type: -
Identifier Source: org_study_id
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