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Clinical Trial Details

Trial ID: L2289
Source ID: NCT05486065
Associated Drug: Semaglutide
Title: A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05486065/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Placebo
Outcome Measures: Primary: Change in Glycated Haemoglobin (HbA1c), Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented., Baseline (week 0) and End of treatment (week 40) | Secondary: Change in Body Weight, Change in body weight from baseline (week 0) to end of treatment (week 40) is presented., Baseline (week 0) and End of treatment (week 40)|Number of Treatment-emergent Adverse Events (TEAEs), An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable \& unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up., From baseline (week 0) up to end of study (week 49)|Number of Treatment-emergent Severe Hypoglycaemic Episodes, Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up., From baseline (week 0) up to end of study (week 49)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 245
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-08
Completion Date: 2023-12-13
Results First Posted: 2024-11-05
Last Update Posted: 2024-11-05
Locations: Univ of Alabama Birmingham, Birmingham, Alabama, 35294, United States|University of Alabama Birmingham, Birmingham, Alabama, 35294, United States|Velocity Clinical Res-Banning, Banning, California, 92220, United States|Southern California Res Ctr, Coronado, California, 92118, United States|Velocity Clin Res Gardena, Gardena, California, 90247, United States|National Research Institute_Huntington Park, Huntington Park, California, 90255, United States|First Valley Med Grp Lancaster, Lancaster, California, 93534, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|San Diego Family Care_San Diego, San Diego, California, 92111, United States|Mills-Peninsula Hlth Services, San Mateo, California, 94401, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Northeast Res Inst. Inc., Jacksonville, Florida, 32204, United States|San Marcus Res Clin Miami Lakes, Miami Lakes, Florida, 33014, United States|Clinical Neuroscience Solution, Orlando, Florida, 32801, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|West Broadway Clinic, Council Bluffs, Iowa, 51501, United States|Cotton O'Neil Clin Research Ctr, Topeka, Kansas, 66606, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|MedStar Community Clin Res Ctr, Hyattsville, Maryland, 20782, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|Endo And Metab Cons, Rockville, Maryland, 20852, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115-5804, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|StudyMetrix Research LLC, Saint Peters, Missouri, 63303, United States|Premier Research Inc., Trenton, New Jersey, 08611, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|Mid Hudson Med Res-New Windsor, New Windsor, New York, 12553, United States|Northport VA Med Ctr Northport, Northport, New York, 11768, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|UNC Eastowne Clinical Research Unit, Chapel Hill, North Carolina, 27514, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Providence Health Partners Ctr, Dayton, Ohio, 45439, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|Velocity Clin Res Grants Pass, Grants Pass, Oregon, 97527, United States|Velocity Clinical Res Medford, Medford, Oregon, 97504, United States|Clinical Research of Philadelphia, Philadelphia, Pennsylvania, 19114, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Clinical Neuroscience Solutions, Memphis, Tennessee, 38119, United States|Amarillo Med Spec LLP, Amarillo, Texas, 79106, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Clinical Inv Spec, Inc.Kenosha, Kenosha, Wisconsin, 53144, United States|University Hospital of Athens ATTIKON, Haidari-Athens, Attica, GR-12462, Greece|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter, Athens, GR-11527, Greece|Alexandra General Hospital, Therapeutic Clinic, Athens, GR-11528, Greece|Iatriko Athinon (Athens Medical Canter), Athens, GR-15125, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, GR-17562, Greece|'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki, GR 54642, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, GR-54643, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|General Hospital of Thessaloniki "G.Papanikolaou", Thessaloniki, GR-57010, Greece|Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ, Szeged, Csongrád-Csanád, H-6725, Hungary|Selye János Kórház és Rendelőintézet, Komárom, Komárom-Esztergom, 2900, Hungary|Szent Margit Rendelőintézet Nonprofit Kft., Budapest, 1032, Hungary|ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1089, Hungary|Bajcsy-Zsilinszky Kórház, Budapest, 1106, Hungary|MH Egészségügyi Központ, Budapest, 1134, Hungary|Markusovszky Egyetemi Oktatókórház, Szombathely, H-9700, Hungary|Clinmedica Research sp. z o.o., Skierniewice, Lodzkie, 96-100, Poland|NBR Polska, Warsaw, Mazowieckie, 00-465, Poland|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|Ko-Med Centra Kliniczne Staszow, Staszow, 28-200, Poland|Velocity Nova Sp. z o.o., Staszow, 28-200, Poland|NBR Polska Tomasz Klodawski, Warszawa, 00-710, Poland|Pro Familia Altera Sp. z o.o., Katowice, Śląskie, 40-648, Poland|Manati Ctr For Clin Research, Manati, 00674, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT05486065

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress