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Clinical Trial Details

Trial ID: L5391
Source ID: NCT05552859
Associated Drug: Insulin Glargine 300 U/Ml
Title: Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
Acronym: TRENT
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05552859/results
Conditions: Type 2 Diabetes Mellitus|Renal Impairment
Interventions: DRUG: Insulin glargine 300 U/mL|DRUG: Insulin degludec 100 U/mL
Outcome Measures: Primary: Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100), Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated., Baseline to 24 weeks | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Change in FPG was calculated by subtracting baseline value from the Week 24 value., Baseline to 24 weeks|Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24, Change in SMPG was calculated by subtracting baseline value from the Week 24 value., Baseline to 24 weeks|Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period, 7-point SMPG profiles were measured at the following 7 points: pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime., Baseline to 24 weeks|Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24, If a patient has a missing HbA1c value at Week 24, it is assumed that they did not reach the HbA1c target of \<7.0%. HbA1c value of 7.0% is equivalent to 53.0 mmol/mol., At week 24|Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period., Any event recorded with Yes as response to the question, "Was a glucose measurement obtained at the time of the event before countermeasure?" and a measurable glucose level of \<70 mg/dL. ADA (American Diabetes Association), Level 1 was defined as a measurable glucose concentration of \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L)., Baseline to end of study (25 weeks)|Rate of Hypoglycemia Per Participant-year, Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window), Baseline to end of study (25 weeks)]|Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks), Hypoglycemic events measured at the following intervals: Weeks 1-12 and Weeks 13-24., Baseline to end of study (25 weeks)|The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period., The time range for this outcome measure was 00:00 to 05:59, both inclusive. Hypoglycemia Categories \[(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification\], Baseline to end of study (25 weeks)|Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs), Adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest (AESIs), and other safety evaluations, including vital signs and body weight., Baseline to end of study (25 weeks)
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 62
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-12-05
Completion Date: 2023-08-04
Results First Posted: 2024-09-05
Last Update Posted: 2024-09-05
Locations: Yuma Clinical Trials, LLC Site Number: 8400028, Yuma, Arizona, 85364-7110, United States|American Clinical Trials Site Number: 8400014, Buena Park, California, 90620-3800, United States|Clearview Medical Research LLC Site Number: 8400021, Canyon Country, California, 91351-4138, United States|Torrance Clinical Research Institute Site Number: 8400003, Lomita, California, 90717-2101, United States|Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026, Santa Clarita, California, 91321-2454, United States|San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023, Van Nuys, California, 91405-3605, United States|Chase Medical Research LLC Site Number: 8400007, Waterbury, Connecticut, 06708, United States|Innovative Research of West Florida Site Number: 8400016, Clearwater, Florida, 33756-2004, United States|Evolution Clinical Trials Site number: 8400034, Hialeah Gardens, Florida, 33016, United States|Wellness Research Center Inc - Miami Site Number: 8400010, Miami, Florida, 33135-1601, United States|Med Research of Florida, LLC Investigator Site: 8400033, Miami, Florida, 33186, United States|Florida Institute For Clinical Research LLC Site Number: 8400004, Orlando, Florida, 32825, United States|Emory University Site Number: 8400032, Atlanta, Georgia, 30303, United States|Agile Clinical Research Trials, LLC Site Number: 8400001, Atlanta, Georgia, 30328-5532, United States|Centricity Research Site Number: 8400006, Columbus, Georgia, 31904, United States|Georgia Clinical Research Site Number: 8400009, Lawrenceville, Georgia, 30044-5896, United States|Endocrine and Metabolic Consultants Research Center Site Number: 8400031, Rockville, Maryland, 20852, United States|Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019, Las Vegas, Nevada, 89113-3628, United States|Mid Hudson Medical Research PLLC Site Number: 8400024, New Windsor, New York, 12553-7754, United States|Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008, Morehead City, North Carolina, 28557-3126, United States|Advanced Medical Research Site Number: 8400012, Maumee, Ohio, 43537-1863, United States|Capital Area Research LLC Site Number: 8400029, Newport, Pennsylvania, 17074, United States|Jefferson University Physicians (JUP) Site Number: 8400025, Philadelphia, Pennsylvania, 19107-6810, United States|Holston Medical Group PC Site Number: 8400018, Bristol, Tennessee, 37620-7353, United States|Frontier Medical Center Site Number: 8400035, El Paso, Texas, 79935-4202, United States|Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015, Fort Worth, Texas, 76132-4242, United States|Juno Research, LLC Site Number: 8400017, Houston, Texas, 77054, United States|Reichman and Associates Site Number: 8400013, Houston, Texas, 77074-1691, United States|Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027, Lufkin, Texas, 75904-3163, United States|Northeast Clinical Research of San Antonio LLC Site Number: 8400022, Schertz, Texas, 78154-1403, United States|Consano Clinical Research Site Number: 8400030, Shavano Park, Texas, 78231, United States|David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005, Suffolk, Virginia, 23435-3763, United States|Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001, Krnov, Moravskoslezský Kraj, 794 01, Czechia|Agentura Science Pro spol. s.r.o.Site Number: 2030002, Olomouc, Olomoucký Kraj, 779 00, Czechia|Institut Klinicke A Experimentalni Mediciny Site Number: 2030006, Prague, Praha, Hlavní Mesto, 140 21, Czechia|Diacentrum Brandys n. L. Site Number: 2030004, Brandýs Nad Labem-Stará Boleslav, 250 01, Czechia|Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005, Jílové U Prahy, 254 00, Czechia|Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007, Praha, 100 34, Czechia|Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006, Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary|Markusovszky Egyetemi Oktatókórház Site Number: 3480001, Szombathely, Vas, 9700, Hungary|Csolnoky Ferenc Korhaz Site Number: 3480005, Balatonfüred, Veszprém, 8230, Hungary|Zala Megyei Szent Rafael Korhaz Site Number: 3480002, Zalaegerszeg, Zala, 8904, Hungary|Magyar Honvédség Egészségügyi Központ Site Number: 3480003, Budapest, 1134, Hungary|Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004, Kaposvár, 7400, Hungary|Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009, Wroclaw, Dolnoslaskie, 50-127, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008, Lublin, Lubelskie, 20-538, Poland|KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010, Puławy, Lubelskie, 24-100, Poland|KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012, Zamość, Lubelskie, 22-400, Poland|Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016, Kraków, Malopolskie, 31-548, Poland|Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015, Radom, Mazowieckie, 26-610, Poland|NBR Polska Site Number: 6160003, Warszawa, Mazowieckie, 00-465, Poland|Centralny Szpital Kliniczny MSW Site Number: 6160005, Warszawa, Mazowieckie, 02-507, Poland|NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014, Gdańsk, Pomorskie, 80-858, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001, Częstochowa, Slaskie, 42-207, Poland|Specjalistyczna Praktyka Lekarska Site Number: 6160004, Lubliniec, Slaskie, 42-700, Poland|KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011, Staszów, Swietokrzyskie, 28-200, Poland|Centrum Medyczne OMEDICA Site Number: 6160013, Poznań, Wielkopolskie, 60-111, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017, Lódz, 90-132, Poland|Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014, Poznan, 61-655, Poland|Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002, Radom, 26-600, Poland|ETG Skierniewice - PPDS Site Number: 6160006, Skierniewice, Lódzkie, Poland|ETG Lodz Site Number: 6160018, Łódź, 90-302, Poland|Clinical Hospital Centar Zvezdara Site Number: 6880001, Belgrade, 11000, Serbia|University Clinical Center of Serbia - PPDS Site Number: 6880003, Belgrade, 11000, Serbia|University Clinical Center of Serbia - PPDS Site Number: 6880004, Belgrade, 11000, Serbia|University Clinical Center Nis Site Number: 6880002, Niš, 18 000, Serbia|University Clinical Center Nis Site Number: 6880005, Niš, 18 000, Serbia|Health Center Zajecar Site Number: 6880006, Zaječar, 19000, Serbia
URL: https://clinicaltrials.gov/show/NCT05552859

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress