| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., Baseline (Week 0), Week 26 | Secondary: Change in Fasting Plasma Glucose (FPG), Change in FPG from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., Baseline (Week 0), Week 26|Percentage of Time in Target-range 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System, The percentage of time in target-range 3.9-10.0 mmol/L (70-180 milligrams per deciliter \[mg/dL\]) using continuous glucose monitoring (CGM) system is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., From week 22 to week 26|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction, Change in DTSQs in total treatment satisfaction from baseline (week 0) to week 26 is presented. The DTSQ domain score in total treatment satisfaction was calculated by adding the six item scores of items 1, 4-8. Higher scores indicate higher levels of treatment satisfaction for items 1, 4 -8. For items 2 and 3 a higher score indicates a participant perceived experience of hyperglycaemia and hypoglycaemia. Lower scores indicate a perception of blood glucose levels being unacceptably high (item 2) or low (item 3). The score has a minimum of 0 and a maximum of 36. The outcome data was evaluated based on in-trial observation period. In-trial observation period started at randomisation and ended at the date of: Last direct participant-site contact, withdrawal for participants who withdrew their informed consent, last participant-investigator contact as defined by the investigator for participants who were lost to follow-up and death for participants who died before any of the above., Baseline (Week 0), Week 26|Number of Severe Hypoglycaemic Episodes (Level 3), Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product., From baseline (week 0) to week 31|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter), Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product., From baseline (week 0) to week 31|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3), Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the in-trial observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period., From baseline (week 0) to week 31|Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Percentage of tiime spent \< 3.0 millimoles per liter (mmol/L) (54 mg/dL) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., From week 22 to week 26|Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Percentage of time spent \> 10 millimoles per liter (mmol/L) (180 milligrams per deciliter \[mg/dL\]) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., From week 22 to week 26|Mean Weekly Insulin Dose, Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product., From week 24 to week 26|Change in Body Weight, Change in body weight from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above., Baseline (Week 0), Week 26
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| Locations: |
American Clinical Trials, Buena Park, California, 90620, United States|Valley Research, Fresno, California, 93720, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Clinical Trials Research_Sacramento, Lincoln, California, 95648, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|Velocity Clin. Res Valparaiso, Valparaiso, Indiana, 46383, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, 70119, United States|Ileana J Tandron APMC, Slidell, Louisiana, 70461-4231, United States|Endo And Metab Cons, Rockville, Maryland, 20852, United States|MassResearch, LLC, Waltham, Massachusetts, 02453, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Diabetes and Thyroid Ctr of FW, Fort Worth, Texas, 76132, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Simcare Medical Research, LLC, Sugar Land, Texas, 77478, United States|Hillcrest Family Health Center, Waco, Texas, 76708, United States|Capital Clin Res Ctr,LLC, Olympia, Washington, 98502, United States|'Medical center Medi city 21' OOD, Kyustendil, 2500, Bulgaria|OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov, Plovdiv, 4002, Bulgaria|ASOMCEM - IP - Dr. Antoanela Slavcheva, Ruse, 7002, Bulgaria|MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases, Sofia, 1606, Bulgaria|InnoDiab Forschung GmbH, Essen, 45136, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Milek, Hohenmölsen, Hohenmölsen, 06679, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|Wenzl-Bauer, Rehlingen-Siersb., Rehlingen-Siersburg, 66780, Germany|Marienhospital Stuttgart - Innere Medizin 1, Stuttgart, 70199, Germany|Erlinger, Stuttgart, 70378, Germany|Hayashi Diabetes Clinic, Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, 819-0006, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Yuri Ono Clinic, Sapporo-shi, Hokkaido, 060-0001, Japan|Oyama East Clinic, Tochigi, 323-0022, Japan|Juntendo University Hospital_Tokyo, Tokyo, 113-8431, Japan|Noritake Clinic, Ushiku-shi, Ibaraki, 300-1207, Japan|Seoul National University Bundang Hospital, Gyeonggi-do, 13620, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 03722, Korea, Republic of|Nowon Eulji Medical Center, Eulji University, Seoul, 139-827, Korea, Republic of|Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|NZOZ "DiabMed" Poradnia Diabetologiczna, Poznan, 60-821, Poland|Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warszawa, 02-507, Poland|Unidade Local de Saúde de Matosinhos, Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal|Hospital Garcia de Orta, Almada, 2805-267, Portugal|Centro Hospitalar Lisboa Ocidental, Lisboa, 1349-019, Portugal|Unidade Local de Saúde de Santo António, E.P.E, Porto, 4099-001, Portugal|Centro Hospitalar de São João, Porto, 4200-319, Portugal|Hospital da Luz Arrabida, Vila Nova de Gaia, 4400-346, Portugal|Greenacres Hospital, Port Elizabeth, Eastern Cape, 6045, South Africa|Medi-Clinic Bloemfontein, Bloemfontein, Free State, 9301, South Africa|Hemant Makan, Johannesburg, Gauteng, 1827, South Africa|Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, 2013, South Africa|Centre for Diabetes, Johannesburg, Gauteng, 2198, South Africa|Dr A Amod, Durban, KwaZulu-Natal, 4092, South Africa|Clinic of Medical Academy, Dnipro, Dnipro, 49038, Ukraine|Department of Medical Service and Rehabilitation of "Artem", Kyiv, 04053, Ukraine|Institute of Endocrinology and Metabolism of AMSU, Kyiv, 04114, Ukraine|Ternopil Central District Hospital, Ternopil, 46001, Ukraine
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