A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin Degludec/Insulin Aspart
- Registration Number
- NCT04042441
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1122
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ryzodeg® as per local practice Insulin Degludec/Insulin Aspart 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.
- Primary Outcome Measures
Name Time Method Change in local laboratory measured glycosylated haemoglobin (HbA1c) From baseline (week 0) to end of study (week 26-36) Percentage point
- Secondary Outcome Measures
Name Time Method HbA1c less than 7% (Yes/No) At the end of study (week 26-36) Percentage of patients
HbA1c less than pre-defined individual treatment target (Yes/No) At the end of study (week 26-36) Percentage of patients
Change in insulin dose (total, basal, prandial) From baseline (week 0) to end of study (week 26-36) units/day
Number of patient recollection of overall severe hypoglycaemic episodes At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study Number of episodes
Discontinue treatment with Ryzodeg® during the treatment period (Yes/No) At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation Percentage of patients
Change in local laboratory measured FPG From baseline (week 0) to end of study (week 26-36) mmol/L
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study Number of episodes
Reason for initiating Ryzodeg® (pre-specified response option(s)) At baseline (week 0) Percentage of patients per response option
Time period from initiation to discontinuation of treatment with Ryzodeg® At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation Days
Change in local laboratory measured fasting plasma glucose (FPG) From baseline (week 0) to end of study (week 26-36) mg/dL
Change in body weight From baseline (week 0) to end of study (week 26-36) Kg
Number of patient recollection of non-severe hypoglycaemic episodes At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study Number of episodes
Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s)) At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation Percentage of patients per response option
Number of weekly self-measured plasma glucose (SMPG) measurements At end of study (week 26-36). Measurements occurring within 7 days prior to end of study Number of measurements
Trial Locations
- Locations (64)
Saudi German Hospital
🇸🇦Jeddah, Saudi Arabia
My clinic
🇸🇦Jeddah, Saudi Arabia
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, Orissa, India
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
Umm Alquara University Hospital
🇸🇦Makkah, Saudi Arabia
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
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
Borneo Medical Centre
🇲🇾Kuching, Malaysia
KPJ Kuching
🇲🇾Kuching, Malaysia
Mahkota Medical Center
🇲🇾Melaka, Malaysia
Pantai Hospital Ayer Keroh
🇲🇾Melaka, Malaysia
Island Hospital
🇲🇾Penang, Malaysia
Klinik Chong
🇲🇾Perak, Malaysia
Remedic Clinic
🇲🇾Perlis, Malaysia
Hospital Putrajaya
🇲🇾Putrajaya, Malaysia
Subang Jaya Medical Center
🇲🇾Selangor, Malaysia
Thomson Hospital
🇲🇾Selangor, Malaysia
Panay Healthcare Medical Center
🇵🇭Aklan, Philippines
Perpetual Succor Hospital
🇵🇭Cebu City, Philippines
Davao Doctors Hospital
🇵🇭Davao City, Philippines
Iloilo Diabetes Care Center
🇵🇭Iloilo, 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
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