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

NCT04042441 | Completed

• 2 other identifiers: NN5401-4525U1111-1227-8654
• Study Type: observational
• Target: 1,122
• Locations: 6 countries
• Sites: 64

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in local laboratory measured glycosylated haemoglobin (HbA1c)

  Percentage point

  From baseline (week 0) to end of study (week 26-36)

Secondary Outcomes (18)

• HbA1c less than 7% (Yes/No)

  At the end of study (week 26-36)

• HbA1c less than pre-defined individual treatment target (Yes/No)

  At the end of study (week 26-36)

• Change in local laboratory measured fasting plasma glucose (FPG)

  From baseline (week 0) to end of study (week 26-36)

• Change in local laboratory measured FPG

  From baseline (week 0) to end of study (week 26-36)

• Change in insulin dose (total, basal, prandial)

  From baseline (week 0) to end of study (week 26-36)

Study Arms (1)

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.

Drug: Insulin Degludec/Insulin Aspart

Interventions

Insulin Degludec/Insulin Aspart DRUG

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.

Ryzodeg® as per local practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (64)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, 2500, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

South Australian Endocrine Research

Keswick, South Australia, 5035, Australia

Location

Hobart Cardiology

Hobart, Tasmania, 7000, Australia

Location

Box Hill Specialist Consulting rooms

Box Hill, Victoria, 3128, Australia

Location

Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

Rockingham General Hospital

Cooloongup, Western Australia, 6168, Australia

Location

Excelcare Hospital

Guwahati, Assam, 781033, India

Location

Columbia Asia Hospital

Bangalore, Karnataka, 560024, India

Location

Pace Diabetes Center

Bangalore, Karnataka, 560043, India

Location

DEW Medicare & Trinity hospital

Nagpur, Maharashtra, 440015, India

Location

Max Super Speciality Shalimar Bhagh

Delhi, New Delhi, 110088, India

Location

AMRI Hospital

Bhubaneswar, Odisha, 751030, India

Location

Fortis Heart Institute and Multispeciality Hospital

Mohali, Punjab, 160062, India

Location

R.M. Diabetes Education & Research Foundation

Chennai, Tamil Nadu, 600040, India

Location

Narayana Superspeciality Hospital

Howrah, West Bengal, 711103, India

Location

Fortis Hospital

New Delhi, 110088, India

Location

Island Hospital

George Town, 10450, Malaysia

Location

Remedic Clinic

Kangar, 01000, Malaysia

Location

Pantai Hospital

Kedah, 08000, Malaysia

Location

Kota Bahru Medical Centre Sdn Bhd

Kelantan, 15200, Malaysia

Location

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Gleneagles Hospital

Kuala Lumpur, 50450, Malaysia

Location

Subang Jaya Medical Center

Kuala Selangor, 47500, Malaysia

Location

Thomson Hospital

Kuala Selangor, 47810, Malaysia

Location

Borneo Medical Centre

Kuching, 93350, Malaysia

Location

KPJ Kuching

Kuching, 93350, Malaysia

Location

Mahkota Medical Center

Malacca, 75000, Malaysia

Location

Pantai Hospital Ayer Keroh

Malacca, 75450, Malaysia

Location

Klinik Chong

Perak, 35800, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Panay Healthcare Medical Center

Aklan, Philippines

Location

Perpetual Succor Hospital

Cebu City, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

Iloilo Diabetes Care Center

Iloilo City, 5000, Philippines

Location

Makati Medical Center

Makati City, 1229, Philippines

Location

University of Santo Tomas

Manila, 1015, Philippines

Location

Manila Doctor's Hospital

Manila, Philippines

Location

University of Sto. Tomas Hospital

Manila, Philippines

Location

St. Luke's Medical Center

Quezon City, 1102, Philippines

Location

Providence Hospital

Quezon City, Philippines

Location

University of the East-Ramon Magsaysay Memorial Medical Ctr

Quezon City, Philippines

Location

King Abdulaziz University Hospital

Jeddah, 22252, Saudi Arabia

Location

Dr Bakhsh Hospital

Jeddah, 23216, Saudi Arabia

Location

Dr. Ghassan N. Faroun Hospital

Jeddah, 23521, Saudi Arabia

Location

Saudi German Hospital

Jeddah, 23521, Saudi Arabia

Location

My clinic

Jeddah, Saudi Arabia

Location

Umm Alquara University Hospital

Mecca, 24381, Saudi Arabia

Location

Specialized medical center

Riyadh, 12311, Saudi Arabia

Location

Riyadh Care Hospital

Riyadh, 14214, Saudi Arabia

Location

National Guard Hospital

Riyadh, 14611, Saudi Arabia

Location

Dallah Hospital

Riyadh, 14963, Saudi Arabia

Location

Greenacres Hospital

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

ProHealth Wellness Centre

Port Elizabeth, Eastern Cape, 6201, South Africa

Location

Hemant Makan

Johannesburg, Gauteng, 1827, South Africa

Location

Dr Moosa's Rooms

Lenasia, Gauteng, 1827, South Africa

Location

Prof P. Joshi

Pretoria, Gauteng, 0181, South Africa

Location

Dr H Bacus

Berea, KwaZulu-Natal, 4091, South Africa

Location

Union Hospital

Alberton, 1449, South Africa

Location

Medi-Clinic Bloemfontein

Bloemfontein, 9301, South Africa

Location

Related Publications (4)

• 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.

  PMID: 39171857 RESULT

• 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.

  PMID: 39464932 DERIVED

• 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.

  PMID: 35752730 DERIVED

• 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.

  PMID: 34637072 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec, insulin aspart drug combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: July 29, 2019
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (10); PH (11); AU (10); ZA (9); MY (14); SA (10)