Sanofi
The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.
Type 2 Diabetes Mellitus
Renal Impairment
Insulin glargine 300 U/mL
Insulin degludec 100 U/mL
Phase 4
The trial will consist of the following periods: A screening period of up to 2 weeks, A 24-week, open-label treatment period, including a titration period and a maintenance period. A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.
Study Type : | Interventional |
Estimated Enrollment : | 62 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial |
Actual Study Start Date : | December 5, 2022 |
Estimated Primary Completion Date : | July 28, 2023 |
Estimated Study Completion Date : | August 4, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Gla-300 arm Gla-300 will be administered once daily for 24 weeks |
Drug: Insulin glargine 300 U/mL |
Active Comparator: IDeg-100 arm Ideg-100 will be administered once daily for 24 weeks |
Drug: Insulin degludec 100 U/mL |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Yuma Clinical Trials, LLC Site Number: 8400028
Yuma, Arizona, United States, 85364-7110
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American Clinical Trials Site Number: 8400014
Buena Park, California, United States, 90620-3800
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Clearview Medical Research LLC Site Number: 8400021
Canyon Country, California, United States, 91351-4138
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Torrance Clinical Research Institute Site Number: 8400003
Lomita, California, United States, 90717-2101
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Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026
Santa Clarita, California, United States, 91321-2454
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San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023
Van Nuys, California, United States, 91405-3605
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Chase Medical Research LLC Site Number: 8400007
Waterbury, Connecticut, United States, 06708
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Innovative Research of West Florida Site Number: 8400016
Clearwater, Florida, United States, 33756-2004
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Evolution Clinical Trials Site number: 8400034
Hialeah Gardens, Florida, United States, 33016
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Wellness Research Center Inc - Miami Site Number: 8400010
Miami, Florida, United States, 33135-1601
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Med Research of Florida, LLC Investigator Site: 8400033
Miami, Florida, United States, 33186
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Florida Institute For Clinical Research LLC Site Number: 8400004
Orlando, Florida, United States, 32825
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Emory University Site Number: 8400032
Atlanta, Georgia, United States, 30303
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Agile Clinical Research Trials, LLC Site Number: 8400001
Atlanta, Georgia, United States, 30328-5532
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Centricity Research Site Number: 8400006
Columbus, Georgia, United States, 31904
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Georgia Clinical Research Site Number: 8400009
Lawrenceville, Georgia, United States, 30044-5896
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Endocrine and Metabolic Consultants Research Center Site Number: 8400031
Rockville, Maryland, United States, 20852
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Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019
Las Vegas, Nevada, United States, 89113-3628
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Mid Hudson Medical Research PLLC Site Number: 8400024
New Windsor, New York, United States, 12553-7754
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Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008
Morehead City, North Carolina, United States, 28557-3126
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Advanced Medical Research Site Number: 8400012
Maumee, Ohio, United States, 43537-1863
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Capital Area Research LLC Site Number: 8400029
Newport, Pennsylvania, United States, 17074
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Jefferson University Physicians (JUP) Site Number: 8400025
Philadelphia, Pennsylvania, United States, 19107-6810
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Holston Medical Group PC Site Number: 8400018
Bristol, Tennessee, United States, 37620-7353
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Frontier Medical Center Site Number: 8400035
El Paso, Texas, United States, 79935-4202
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Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015
Fort Worth, Texas, United States, 76132-4242
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Juno Research, LLC Site Number: 8400017
Houston, Texas, United States, 77054
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Reichman and Associates Site Number: 8400013
Houston, Texas, United States, 77074-1691
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Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027
Lufkin, Texas, United States, 75904-3163
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Northeast Clinical Research of San Antonio LLC Site Number: 8400022
Schertz, Texas, United States, 78154-1403
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Consano Clinical Research Site Number: 8400030
Shavano Park, Texas, United States, 78231
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David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005
Suffolk, Virginia, United States, 23435-3763
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Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001
Krnov, Moravskoslezský Kraj, Czechia, 794 01
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Agentura Science Pro spol. s.r.o.Site Number: 2030002
Olomouc, Olomoucký Kraj, Czechia, 779 00
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Institut Klinicke A Experimentalni Mediciny Site Number: 2030006
Prague, Praha, Hlavní Mesto, Czechia, 140 21
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Brandýs Nad Labem-Stará Boleslav, Szabolcs-Szatmár-Bereg, Czechia, 250 01
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Jílové U Prahy, Vas, Czechia, 254 00
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Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007
Praha, Veszprém, Czechia, 100 34
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Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006
Nyíregyháza, Zala, Hungary, 4400
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Markusovszky Egyetemi Oktatókórház Site Number: 3480001
Szombathely, Dolnoslaskie, Hungary, 9700
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Csolnoky Ferenc Korhaz Site Number: 3480005
Balatonfüred, Lubelskie, Hungary, 8230
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Zala Megyei Szent Rafael Korhaz Site Number: 3480002
Zalaegerszeg, Lubelskie, Hungary, 8904
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Budapest, Lubelskie, Hungary, 1134
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Kaposvár, Malopolskie, Hungary, 7400
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Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009
Wroclaw, Mazowieckie, Poland, 50-127
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Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008
Lublin, Mazowieckie, Poland, 20-538
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Puławy, Mazowieckie, Poland, 24-100
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KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012
Zamość, Pomorskie, Poland, 22-400
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Kraków, Slaskie, Poland, 31-548
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Radom, Slaskie, Poland, 26-610
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NBR Polska Site Number: 6160003
Warszawa, Swietokrzyskie, Poland, 00-465
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Centralny Szpital Kliniczny MSW Site Number: 6160005
Warszawa, Wielkopolskie, Poland, 02-507
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NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014
Gdańsk, Poland, 80-858
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NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001
Częstochowa, Poland, 42-207
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Lubliniec, Poland, 42-700
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KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011
Staszów, Poland, 28-200
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Centrum Medyczne OMEDICA Site Number: 6160013
Poznań, Poland, 60-111
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Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017
Lódz, Poland, 90-132
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Poznan, Poland, 61-655
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Skierniewice, Poland, Lódzkie
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ETG Lodz Site Number: 6160018
Łódź, Poland, 90-302
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University Clinical Center of Serbia - PPDS Site Number: 6880003
Belgrade, Serbia, 11000
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University Clinical Center of Serbia - PPDS Site Number: 6880004
Belgrade, Serbia, 11000
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University Clinical Center Nis Site Number: 6880002
Niš, Serbia, 18 000
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University Clinical Center Nis Site Number: 6880005
Niš, Serbia, 18 000
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Health Center Zajecar Site Number: 6880006
Zaječar, Serbia, 19000