| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c) at Week 26, Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' 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); death for participants who died before any of the above., Baseline (week 0), week 26 | Secondary: Change in Glycosylated Haemoglobin (HbA1c) at Week 52, Change in HbA1c from baseline to week 52 is presented. Data is reported for 'in-trial' 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); death for participants who died before any of the above., Baseline (week 0), week 52|Change in Fasting Plasma Glucose (FPG), Change in FPG from baseline to week 26 is presented. Data is reported for 'in-trial' 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); death for participants who died before any of the above., Baseline (week 0), week 26|Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System, Percentage of time in range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 22 to week 26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. Data is reported for 'in-trial' 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); 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 to week 26 is presented. The sum score for DTSQ in total treatment satisfaction was calculated by adding the six item scores of items 1, 4, 5, 6, 7 and 8. The sum score for DTSQ can range from 0 to 36, with 0 being the lowest and 36 being the highest score in total treatment satisfaction. Higher scores on the DTSQ total score indicate higher treatment satisfaction. Data is reported for 'in-trial' 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); death for participants who died before any of the above., Baseline (week 0), week 26|Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26, Number of severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-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 date of the on-treatment period; week 26. On-treatment: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 26|Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57, Number of severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 57|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26, Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 26 are 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. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 26|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57, Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 57 are 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. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 57|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26, Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 are 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. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 26|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57, Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are 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. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 57|Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26, Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. On-treatment period: Onset date on or after first dose of trial product and no later than first date of either follow-up visit, last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for in-trial period., From baseline (week 0) to week 26|Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57, Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From baseline (week 0) to week 57|Percentage of Time spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Percentage of time spent \< 3.0 mmol/L using CGM system from week 22 to week 26 is presented. Time spent below threshold (\< 3.0 mmol/L \[54 mg/dL\]) was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' 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); death for participants who died before any of the above., From week 22 to week 26|Percentage of Time spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Percentage of time spent \> 10 mmol/L using CGM system from week 22 to week 26 is presented. Time spent above threshold (\> 10 mmol/L \[180 mg/dL\]) was defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' 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); death for participants who died before any of the above., From week 22 to week 26|Mean Total Weekly Insulin Dose: From Week 24 to Week 26, Mean total weekly insulin dose from week 24 to week 26 is presented. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From week 24 to week 26|Mean Total Weekly Insulin Dose: From Week 50 to Week 52, Mean total weekly insulin dose from week 50 to week 52 is presented. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period., From week 50 to week 52|Change in Body Weight, Change in body weight from baseline to week 26 is presented. Data is reported for 'in-trial' 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); death for participants who died before any of the above., Baseline (week 0), week 26
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| Locations: |
John Muir Physicians Network, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States|Diabetes & Endocrine Associates, La Mesa, California, 91942, United States|Mills-Peninsula Hlth Services, San Mateo, California, 94401, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80246, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Center For Diabetes & Endo Care, Fort Lauderdale, Florida, 33312, United States|Hanson Clinical Research Center, Port Charlotte, Florida, 33952, United States|Northeast Research Institute, Saint Augustine, Florida, 32080, United States|Physicians Research Assoc. LLC, Lawrenceville, Georgia, 30046, United States|Endo Res Solutions Inc, Roswell, Georgia, 30076, United States|Cotton-O'Neil Diab & Endo Ctr, Topeka, Kansas, 66606, United States|Endo and Metab Consultants, Rockville, Maryland, 20852, United States|Methodist Physicians Clin, Omaha, Nebraska, 68114, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89128, United States|Southern NH Diabetes and Endo_Nashua, Nashua, New Hampshire, 03060, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Prisma Health-Upstate, Greenville, South Carolina, 29605-4254, United States|Univ Diab & Endo Consultants, Chattanooga, Tennessee, 37411, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Texas Diab & Endo, P.A., Austin, Texas, 78731, United States|Texas Diab & Endo, P.A., Austin, Texas, 78749, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|North Texas Endocrine Center, Dallas, Texas, 75231, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|Univ.-Klinik für Innere Medizin, Graz, 8036, Austria|Univ.-Klinik für Innere Medizin I, Innsbruck, 6020, Austria|Fließer-Görzer [Ordination], Saint Stefan, 8511, Austria|Klinik Landstraße, Wien, 1030, Austria|Universitätsklinikum AKH Wien, Wien, 1090, Austria|Klinik Hietzing, Wien, 1130, Austria|Winnipeg Clinic, Winnipeg, Manitoba, R3C 0N2, Canada|Eastern Health Authority, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada|Nova Scotia Hlth Halifax, Halifax, Nova Scotia, B3H 1V7, Canada|Centricity Research LMC, Toronto, Ontario, M4G 3E8, Canada|Ctr de rech Clin de Laval, Laval, Quebec, H7T 2P5, Canada|Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR, Berlin, 13597, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Zentrum für klinische Forschung, Dr. med. Lüdemann, Falkensee, 14612, Germany|Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz, Lingen, 49808, Germany|Die Praxis am Ludwigsplatz, Ludwigshafen, 67059, Germany|Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck, Lübeck, 23562, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|RED-Institut für medizinische Studien und Fortbildung GmbH, Oldenburg I. Holst, 23758, Germany|Zentrum für klinische Studien Alexander Segner, Saint Ingbert-Oberwürzbach, 66386, Germany|Diacare diabetes Hormonal Clinic, Ahmedabad, Gujarat, 380 015, India|Calicut Medical College, Kozhikode, Kerala, 673008, India|All India Institute of Medical Sciences, New Dehli, New Delhi, 110029, India|Care Hospital, Hyderabad, 600034, India|Lady Hardinge Medical College, New Delhi, 110001, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, 695 032, India|Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy|Osp. San Raffaele Diabetes Research Institute, Dibit 1, Milano, 20132, Italy|Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia, Perugia, 06129, Italy|Policlinico Umberto I Clinica Medica DH Diabetologia, Roma, 00161, Italy|Policlinico A. Gemelli, Rome, 00168, Italy|Seino Internal Medicine Clinic, Koriyama-shi, Fukushima, Japan, 963-8851, Japan|Manda Memorial Hospital, Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan|Jinnouchi Hospital, Kumamoto-shi, Kumamoto, Japan, 862-0976, Japan|The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan|H.E.C Science Clinic, Kanagawa, 235-0045, Japan|Yuri Ono Clinic, Sapporo-shi, Hokkaido, 060-0001, Japan|Tokyo Women's Medical University, Tokyo, 162 8666, Japan|Gelre Ziekenhuizen Apeldoorn, Apeldoorn, 7334 DZ, Netherlands|Rijnstate Ziekenhuis, Arnhem, 6815 AD, Netherlands|Ikazia Ziekenhuis, Rotterdam, 3083 AN, Netherlands|National Medical Research Center of Endocrinology, Moscow, 117292, Russian Federation|Endocrinological Dispensary of Department of healthcare ser., Moscow, 119034, Russian Federation|Endocrinology Dpt,Post-Graduate Medical Education Faculty, Moscow, 123448, Russian Federation|SPb SBHI "Snegirev Maternity Hospital No. 6", Saint Petersburg, 191014, Russian Federation|City Consultative & Diagnostic Centre #1, Saint-Petersburg, 194354, Russian Federation|SHI Saratov City Clinical Hospital #9, Saratov, 410031, Russian Federation|Saratov regional clinical hospital, Saratov, 410053, Russian Federation|SPb SBHI City Multifield Hospital #2, St. Petersburg, 194354, Russian Federation|Voronezh Regional Clinical Consultive-diagnostic Centre, Voronezh, 394018, Russian Federation|Yaroslavl Regional Hospital, Yaroslavl, 150062, Russian Federation|Hospital Clinic i Provincial, Barcelona, 08036, Spain|Hospital Clínico Virgen de la Victoria, Málaga, 29010, Spain|Hospital Central de Asturias, Oviedo, 33011, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Cukurova Universitesi Tip Fakultesi, Adana, 01150, Turkey|Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi, Aydin, 09010, Turkey|Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul, 34371, Turkey|TC SB Ist.İl Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi, Istanbul, 34400, Turkey|Haydarpasa Numune Egitim Arastirma Hastanesi Endokrinoloji, Istanbul, 34668, Turkey|Erciyes Universitesi Tip Fakultesi, Kayseri, 38039, Turkey|Inonu University Turgut Ozal Medical Center, Malatya, 44280, Turkey|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Addenbrooke's Hospital_Cambridge, Cambridge, CB2 0QQ, United Kingdom|Royal Derby Hospital, Derby, DE1 2QY, United Kingdom|Western General Hospital, Edinburgh, EH4 2XU, United Kingdom|Royal Surrey County Hospital, Guildford, GU2 7XX, United Kingdom|Churchill Hospital, Oxford, OX3 7LE, United Kingdom|Lister Hospital, Stevenage, SG1 4AB, United Kingdom|Joint Clinical Research Facility - Swansea, Swansea, SA2 8PP, United Kingdom
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