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Clinical Trial Details

Trial ID: L3293
Source ID: NCT05514535
Associated Drug: Semaglutide
Title: A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Obesity
Interventions: DRUG: Semaglutide|DRUG: Insuline glargine U100 (reduced)|DRUG: Insuline glargine U100 (titrated)
Outcome Measures: Primary: Change in Glycated Haemoglobin (HbA1c), Non-inferiority of semaglutide s.c. as add-on to dose-reduced insulin glargine to that of titrated insulin glargine will be assessed based on the clinically acceptable margin of 0.3 percentage (%) for the mean treatment difference in HbA1c. Measured as percentage., From baseline (week 0) to end of treatment (week 40) | Secondary: Change in Body Weight, Measured as kilogram, From baseline (week 0) to end of treatment (week 40)|Relative Change in Daily Insulin Dose, Measured as percentage, From baseline (week 0) to end of treatment (week 40)|Change in HbA1c, Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage., From baseline (week 0) to end of treatment (week 40)|Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc), The questionnaire has been designed to measure the change in the level of satisfaction with diabetes treatment regimens in participants with diabetes who have had a recent intervention. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. Measured as score on a scale., At end of treatment (week 40)|Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No), Measured as count of participants, At end of treatment (week 40)|Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No), Measured as count of participants, At end of treatment (week 40)|Participants Achieving: HbA1c less than 7 Percentage (Yes/No), Measured as count of participants, At end of treatment (week 40)|Number of Severe Hypoglycaemic Episodes (Level 3), Measured as number of episodes, From baseline (week 0) to end of treatment (week 40)|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter), Measured as number of episodes, From baseline (week 0) to end of treatment (week 40)|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3), Measured as number of episodes, From baseline (week 0) to end of treatment (week 40)|Participants Achieving All of The Following Targets: HbA1c Reduced From Baseline by At Least 0.3 %; Insulin Dose Reduced From Baseline; No Hypoglycaemic Episodes; No Weight Gain, No hypoglycaemic episodes defined as less than 3.9 mmol/L \[70 milligrams per decilitre (mg/dL)\] confirmed by Blood Glucose meter. Outcome measure measured as count of participants., At end of treatment (week 40)|Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs), The questionnaire has been designed to measure satisfaction with diabetes treatment regimens in participants with diabetes. The questionnaire contains 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Measured as score on a scale., From baseline (week 0) to end of treatment (week 40)|Change in Score of Short Form 36 Version 2 (SF-36 v2), The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale., From baseline (week 0) to end of treatment (week 40)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 568
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-29
Completion Date: 2025-04-16
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Valley Research, Fresno, California, 93720, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Loma Linda Univ Hlth Cr Endo, Loma Linda, California, 92354, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Wetlin Research Associates, Inc., San Diego, California, 92120, United States|San Fernando Valley Hlth Inst, West Hills, California, 91304, United States|Encore Medical Research LLC, Hollywood, Florida, 33024, United States|Northeast Res Inst. Inc., Jacksonville, Florida, 32204, United States|Jacksonville Ctr For Clin Res, Jacksonville, Florida, 32216, United States|Elite Research Center, Miami, Florida, 33169, United States|Reyes Clinical Research, Inc, Miami, Florida, 33175, United States|Suncoast Clin Res Port Richey, New Port Richey, Florida, 34652, United States|Suncoast Clinical Research, Inc._New Port Richey, New Port Richey, Florida, 34652, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|Coastal Heritage Clinical Research, Hinesville, Georgia, 31313, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50265, United States|Iowa Diab & Endo Res Center, West Des Moines, Iowa, 50266, United States|Cotton O'Neil Clin Research Ctr, Topeka, Kansas, 66606, United States|Endo & Diab Care Assoc, Slidell, Louisiana, 70461-4231, United States|Endo And Metab Cons, Rockville, Maryland, 20852, United States|Joslin Center For Diabetes, Boston, Massachusetts, 02215, United States|Northern Pines Hlth Ctr, PC, Buckley, Michigan, 49620, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Mercury Str Med Grp, PLLC, Butte, Montana, 59701, United States|Palm Research Center Inc-Vegas, Las Vegas, Nevada, 89128, United States|Southern New Hampshire Diabete, Nashua, New Hampshire, 03063, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Lucas Research Inc., Morehead City, North Carolina, 28557, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|University of Toledo_Toledo, Toledo, Ohio, 43614, United States|Thomas Jefferson Univ Di Rsrch Ctr, Philadelphia, Pennsylvania, 19107, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Accellacare._TN, Knoxville, Tennessee, 37938, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Arlington Family Res. Ctr Inc, Arlington, Texas, 76012-4637, United States|Thyroid Endocrinology & Diabetes PA, Dallas, Texas, 75208, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Diabetes Glandular Diseases Clinic, San Antonio, Texas, 78229, United States|Diabetes Glandular Diseases Clinic, San Antonio, Texas, 78240, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Olympus Family Medicine, Salt Lake City, Utah, 84117, United States|EDUMED s.r.o. Nachod, Náchod, 547 01, Czechia|Diahelp - diabetologie, Pardubice 5, 530 02, Czechia|MUDr. Jitka Zemanova diabetologie a interna, Plzen - Vychodni Predmesti, 326 00, Czechia|Diabet2 s.r.o., Praha 1, 110 00, Czechia|MUDr. Michala Pelikanova, Praha 4, 140 00, Czechia|ResTrial s.r.o., Praha 8, 18100, Czechia|University Hospital of Athens ATTIKON, Athens, Attica, 12462, Greece|University Hospital of Alexandroupolis, Alexandroupolis, 68100, Greece|"Laiko" General Hospital of Athens, Athens, 11527, Greece|Alexandra General Hospital, Therapeutic Clinic, Athens, 11528, Greece|Alexandra General Hospital, Therapeutic Clinic, Athens, GR-11528, Greece|General Hospital of Nikaia, Nikaia, GR-18454, Greece|AHEPA General University Hospital, Thessaloniki, 54636, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, 54643, Greece|"Thermi" Private Hosital, Thessaloniki, 57001, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|Ospedale Santa Maria Goretti - UOD Diabetologia, Latina, LT, 04100, Italy|Ospedale Civile Campo di Marte, Lucca, LU, 55100, Italy|Istituto Scientifico San Raffaele, Milano, MI, 20132, Italy|Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia, Perugia, Umbria, 06129, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy|ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari, Montichiari, 25018, Italy|A.O.U. Università Studi della Campania "Luigi Vanvitelli", Napoli, 80138, Italy|Policlinico A. Gemelli, Rome, 00168, Italy|Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal|Unidade Local De Saude De Almada-Seixal E.P.E., Almada, 2805-267, Portugal|Hospital de Braga, Braga, 4710-243, Portugal|Unidade Local De Saude Do Oeste E.P.E., Caldas da Rainha, 2500-176, Portugal|Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André, Leiria, 2410-197, Portugal|Unidade Local de Saúde de São José EPE - Hospital Curry Cabral, Lisboa, 1050-099, Portugal|Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz, Lisboa, 1349-019, Portugal|Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo, Viana do Castelo, 4904-858, Portugal|SC Grand Med SRL, Oradea, Bihor, 410025, Romania|Spitalul Judetean de Urgenta Targoviste, Targoviste, Dambovita, 130083, Romania|CMI Dr Pop Lavinia, Baia Mare, Maramures, 430222, Romania|Novus Medical Clinica SRL, Ploiesti, Prahova, 100018, Romania|Centrul Medical Sfantul Stefan, Timisoara, Timis, 300125, Romania|Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed, Brasov, 500283, Romania|Clinic of Diabetes Constanta, Constanta, 900591, Romania|SC Consultmed SRL, Iasi, 700547, Romania|Medical Practice SRL, Oradea, 410001, Romania|S.C. Dianutrilife Medica S.R.L., Ploiesti, 100561, Romania|Clinica Korall S.R.L. Satu Mare, Satu-Mare, 440055, Romania|DIA - CLARUS s.r.o., Bojnice, 97201, Slovakia|MediTask, s.r.o, Bratislava, 83103, Slovakia|MEDISPEKTRUM s.r.o., Bratislava, 851 01, Slovakia|Diabetologicka ambulancia DIA-MAX s.r.o., Levice, 93401, Slovakia|IN-DIA s.r.o., Lucenec, 984 01, Slovakia|FUNKYSTUFF s.r.o, Nove Zamky, 940 59, Slovakia|Diakom, spol. s r.o., Poprad, 05801, Slovakia|DIALIPID, s.r.o., Presov, 080 01, Slovakia|Tatratrial s.r.o., Roznava, 04801, Slovakia|BENROD s.r.o., Sturovo, 943 01, Slovakia|Diabetes Care Centre & CDE Centre, Benoni, Gauteng, 1501, South Africa|East Rand Physicians, Johannesburg, Gauteng, 1501, South Africa|Centre for Diabetes, Johannesburg, Gauteng, 2198, South Africa|Dr J Reddy, Durban, KwaZulu-Natal, 4450, South Africa|Dr Pillay's Rooms, Durban, KwaZulu-Natal, 4450, South Africa|Dr T Padayachee, Umkomaas, KwaZulu-Natal, 4170, South Africa|ABS La Roca del Vallés, La Roca del Vallés, 08430, Spain|Hospital Infanta Leonor, Madrid, 28031, Spain|Hospital Son Espases, Palma de Mallorca, 07120, Spain|Hospital Infanta Luisa, Sevilla, 41010, Spain
URL: https://clinicaltrials.gov/show/NCT05514535

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress