| Outcome Measures: |
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)|HbA1c less than pre-defined individual treatment target (Yes/No), Percentage of patients, At the end of study (week 26-36)|Change in local laboratory measured fasting plasma glucose (FPG), mg/dL, From baseline (week 0) to end of study (week 26-36)|Change in local laboratory measured FPG, mmol/L, From baseline (week 0) to end of study (week 26-36)|Change in insulin dose (total, basal, prandial), units/day, From baseline (week 0) to end of study (week 26-36)|Change in body weight, Kg, From baseline (week 0) to end of study (week 26-36)|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®|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|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®|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|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®|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|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®|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|Reason for initiating Ryzodeg® (pre-specified response option(s)), Percentage of patients per response option, At baseline (week 0)|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|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|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
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| Locations: |
Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Illawarra Diabetes Service Clinical Trials & Research Unit, Wollongong, New South Wales, 2500, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia|Mater Hospital Brisbane, South Brisbane, Queensland, 4101, Australia|Lyell McEwin Hospital, Elizabeth Vale, South Australia, 5112, Australia|South Australian Endocrine Research, Keswick, South Australia, 5035, Australia|Hobart Cardiology, Hobart, Tasmania, 7000, Australia|Box Hill Specialist Consulting rooms, Box Hill, Victoria, 3128, Australia|Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, 3004, Australia|Rockingham General Hospital, Cooloongup, Western Australia, 6168, Australia|Excelcare Hospital, Guwahati, Assam, 781033, India|Columbia Asia Hospital, Bangalore, Karnataka, 560024, India|Pace Diabetes Center, Bangalore, Karnataka, 560043, India|DEW Medicare & Trinity hospital, Nagpur, Maharashtra, 440015, India|Max Super Speciality Shalimar Bhagh, Delhi, New Delhi, 110088, India|AMRI Hospital, Bhubaneswar, Orissa, 751030, India|Fortis Heart Institute and Multispeciality Hospital, Mohali, Punjab, 160062, India|R.M. Diabetes Education & Research Foundation, Chennai, Tamil Nadu, 600040, India|Narayana Superspeciality Hospital, Howrah, West Bengal, 711103, India|Fortis Hospital, New Delhi, 110088, India|Pantai Hospital, Kedah, 08000, Malaysia|Kota Bahru Medical Centre Sdn Bhd, Kelantan, 15200, Malaysia|Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, 16150, Malaysia|Gleneagles Hospital, Kuala Lumpur, 50450, Malaysia|Borneo Medical Centre, Kuching, 93350, Malaysia|KPJ Kuching, Kuching, 93350, Malaysia|Mahkota Medical Center, Melaka, 75000, Malaysia|Pantai Hospital Ayer Keroh, Melaka, 75450, Malaysia|Island Hospital, Penang, 10450, Malaysia|Klinik Chong, Perak, 35800, Malaysia|Remedic Clinic, Perlis, 01000, Malaysia|Hospital Putrajaya, Putrajaya, 62250, Malaysia|Subang Jaya Medical Center, Selangor, 47500, Malaysia|Thomson Hospital, Selangor, 47810, Malaysia|Panay Healthcare Medical Center, Aklan, Philippines|Perpetual Succor Hospital, Cebu City, Philippines|Davao Doctors Hospital, Davao City, 8000, Philippines|Iloilo Diabetes Care Center, Iloilo, 5000, Philippines|Makati Medical Center, Makati City, 1229, Philippines|University of Santo Tomas, Manila, 1015, Philippines|Manila Doctor's Hospital, Manila, Philippines|University of Sto. Tomas Hospital, Manila, Philippines|St. Luke's Medical Center, Quezon City, 1102, Philippines|Providence Hospital, Quezon City, Philippines|University of the East-Ramon Magsaysay Memorial Medical Ctr, Quezon City, Philippines|King Abdulaziz University Hospital, Jeddah, 22252, Saudi Arabia|Dr Bakhsh Hospital, Jeddah, 23216, Saudi Arabia|Dr. Ghassan N. Faroun Hospital, Jeddah, 23521, Saudi Arabia|Saudi German Hospital, Jeddah, 23521, Saudi Arabia|My clinic, Jeddah, Saudi Arabia|Umm Alquara University Hospital, Makkah, 24381, Saudi Arabia|Specialized medical center, Riyadh, 12311, Saudi Arabia|Riyadh Care Hospital, Riyadh, 14214, Saudi Arabia|National Guard Hospital, Riyadh, 14611, Saudi Arabia|Dallah Hospital, Riyadh, 14963, Saudi Arabia|Greenacres Hospital, Port Elizabeth, Eastern Cape, 6045, South Africa|Netcare Greenacres Hospital, Port Elizabeth, Eastern Cape, 6045, South Africa|ProHealth Wellness Centre, Port Elizabeth, Eastern Cape, 6201, South Africa|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Dr Moosa's Rooms, Lenasia, Gauteng, 1827, South Africa|Prof P. Joshi, Pretoria, Gauteng, 0181, South Africa|Dr H Bacus, Berea, KwaZulu-Natal, 4091, South Africa|Union Hospital, Alberton, 1449, South Africa|Medi-Clinic Bloemfontein, Bloemfontein, 9301, South Africa
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