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NCT05552859 | Terminated | Type 2 Diabetes Mellitus


Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
Sponsor:

Sanofi

Brief Summary:

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.

Condition or disease

Type 2 Diabetes Mellitus

Renal Impairment

Intervention/treatment

Insulin glargine 300 U/mL

Insulin degludec 100 U/mL

Phase

Phase 4

Detailed Description:

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
Criteria
Inclusion Criteria
  • Is an adult aged ≥18 years at screening.
  • Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of >1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period.
  • Has an HbA1c ≥7.5% and ≤10.5% at screening.
  • Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.
  • Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
  • Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
  • Is capable of understanding the written informed consent, and provides signed written informed consent.
  • Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
  • Is willing and able to fast without having administered study drug for scheduled site visits.
Exclusion Criteria
  • Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
  • Has a body mass index (BMI)* >45 kg/m² during the screening period.
  • Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels).
  • Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening.
  • Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

Location Details


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Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Arizona

Yuma Clinical Trials, LLC Site Number: 8400028

Yuma, Arizona, United States, 85364-7110

Not yet recruiting

United States, California

American Clinical Trials Site Number: 8400014

Buena Park, California, United States, 90620-3800

Not yet recruiting

United States, California

Clearview Medical Research LLC Site Number: 8400021

Canyon Country, California, United States, 91351-4138

Not yet recruiting

United States, California

Torrance Clinical Research Institute Site Number: 8400003

Lomita, California, United States, 90717-2101

Not yet recruiting

United States, California

Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026

Santa Clarita, California, United States, 91321-2454

Not yet recruiting

United States, California

San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023

Van Nuys, California, United States, 91405-3605

Not yet recruiting

United States, Connecticut

Chase Medical Research LLC Site Number: 8400007

Waterbury, Connecticut, United States, 06708

Not yet recruiting

United States, Florida

Innovative Research of West Florida Site Number: 8400016

Clearwater, Florida, United States, 33756-2004

Not yet recruiting

United States, Florida

Evolution Clinical Trials Site number: 8400034

Hialeah Gardens, Florida, United States, 33016

Not yet recruiting

United States, Florida

Wellness Research Center Inc - Miami Site Number: 8400010

Miami, Florida, United States, 33135-1601

Not yet recruiting

United States, Florida

Med Research of Florida, LLC Investigator Site: 8400033

Miami, Florida, United States, 33186

Not yet recruiting

United States, Florida

Florida Institute For Clinical Research LLC Site Number: 8400004

Orlando, Florida, United States, 32825

Not yet recruiting

United States, Georgia

Emory University Site Number: 8400032

Atlanta, Georgia, United States, 30303

Not yet recruiting

United States, Georgia

Agile Clinical Research Trials, LLC Site Number: 8400001

Atlanta, Georgia, United States, 30328-5532

Not yet recruiting

United States, Georgia

Centricity Research Site Number: 8400006

Columbus, Georgia, United States, 31904

Not yet recruiting

United States, Georgia

Georgia Clinical Research Site Number: 8400009

Lawrenceville, Georgia, United States, 30044-5896

Not yet recruiting

United States, Maryland

Endocrine and Metabolic Consultants Research Center Site Number: 8400031

Rockville, Maryland, United States, 20852

Not yet recruiting

United States, Nevada

Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019

Las Vegas, Nevada, United States, 89113-3628

Not yet recruiting

United States, New York

Mid Hudson Medical Research PLLC Site Number: 8400024

New Windsor, New York, United States, 12553-7754

Not yet recruiting

United States, North Carolina

Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008

Morehead City, North Carolina, United States, 28557-3126

Not yet recruiting

United States, Ohio

Advanced Medical Research Site Number: 8400012

Maumee, Ohio, United States, 43537-1863

Not yet recruiting

United States, Pennsylvania

Capital Area Research LLC Site Number: 8400029

Newport, Pennsylvania, United States, 17074

Not yet recruiting

United States, Pennsylvania

Jefferson University Physicians (JUP) Site Number: 8400025

Philadelphia, Pennsylvania, United States, 19107-6810

Not yet recruiting

United States, Tennessee

Holston Medical Group PC Site Number: 8400018

Bristol, Tennessee, United States, 37620-7353

Not yet recruiting

United States, Texas

Frontier Medical Center Site Number: 8400035

El Paso, Texas, United States, 79935-4202

Not yet recruiting

United States, Texas

Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015

Fort Worth, Texas, United States, 76132-4242

Not yet recruiting

United States, Texas

Juno Research, LLC Site Number: 8400017

Houston, Texas, United States, 77054

Not yet recruiting

United States, Texas

Reichman and Associates Site Number: 8400013

Houston, Texas, United States, 77074-1691

Not yet recruiting

United States, Texas

Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027

Lufkin, Texas, United States, 75904-3163

Not yet recruiting

United States, Texas

Northeast Clinical Research of San Antonio LLC Site Number: 8400022

Schertz, Texas, United States, 78154-1403

Not yet recruiting

United States, Texas

Consano Clinical Research Site Number: 8400030

Shavano Park, Texas, United States, 78231

Not yet recruiting

United States, Virginia

David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005

Suffolk, Virginia, United States, 23435-3763

Not yet recruiting

Czechia, Moravskoslezský Kraj

Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001

Krnov, Moravskoslezský Kraj, Czechia, 794 01

Not yet recruiting

Czechia, Olomoucký Kraj

Agentura Science Pro spol. s.r.o.Site Number: 2030002

Olomouc, Olomoucký Kraj, Czechia, 779 00

Not yet recruiting

Czechia, Praha, Hlavní Mesto

Institut Klinicke A Experimentalni Mediciny Site Number: 2030006

Prague, Praha, Hlavní Mesto, Czechia, 140 21

Not yet recruiting

Czechia, Szabolcs-Szatmár-Bereg

Diacentrum Brandys n. L. Site Number: 2030004

Brandýs Nad Labem-Stará Boleslav, Szabolcs-Szatmár-Bereg, Czechia, 250 01

Not yet recruiting

Czechia, Vas

Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005

Jílové U Prahy, Vas, Czechia, 254 00

Not yet recruiting

Czechia, Veszprém

Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007

Praha, Veszprém, Czechia, 100 34

Not yet recruiting

Hungary, Zala

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006

Nyíregyháza, Zala, Hungary, 4400

Not yet recruiting

Hungary, Dolnoslaskie

Markusovszky Egyetemi Oktatókórház Site Number: 3480001

Szombathely, Dolnoslaskie, Hungary, 9700

Not yet recruiting

Hungary, Lubelskie

Csolnoky Ferenc Korhaz Site Number: 3480005

Balatonfüred, Lubelskie, Hungary, 8230

Not yet recruiting

Hungary, Lubelskie

Zala Megyei Szent Rafael Korhaz Site Number: 3480002

Zalaegerszeg, Lubelskie, Hungary, 8904

Not yet recruiting

Hungary, Lubelskie

Magyar Honvédség Egészségügyi Központ Site Number: 3480003

Budapest, Lubelskie, Hungary, 1134

Not yet recruiting

Hungary, Malopolskie

Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004

Kaposvár, Malopolskie, Hungary, 7400

Not yet recruiting

Poland, Mazowieckie

Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009

Wroclaw, Mazowieckie, Poland, 50-127

Not yet recruiting

Poland, Mazowieckie

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008

Lublin, Mazowieckie, Poland, 20-538

Not yet recruiting

Poland, Mazowieckie

KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010

Puławy, Mazowieckie, Poland, 24-100

Not yet recruiting

Poland, Pomorskie

KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012

Zamość, Pomorskie, Poland, 22-400

Not yet recruiting

Poland, Slaskie

Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016

Kraków, Slaskie, Poland, 31-548

Not yet recruiting

Poland, Slaskie

Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015

Radom, Slaskie, Poland, 26-610

Not yet recruiting

Poland, Swietokrzyskie

NBR Polska Site Number: 6160003

Warszawa, Swietokrzyskie, Poland, 00-465

Not yet recruiting

Poland, Wielkopolskie

Centralny Szpital Kliniczny MSW Site Number: 6160005

Warszawa, Wielkopolskie, Poland, 02-507

Not yet recruiting

Poland,

NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014

Gdańsk, Poland, 80-858

Not yet recruiting

Poland,

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001

Częstochowa, Poland, 42-207

Not yet recruiting

Poland,

Specjalistyczna Praktyka Lekarska Site Number: 6160004

Lubliniec, Poland, 42-700

Not yet recruiting

Poland,

KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011

Staszów, Poland, 28-200

Not yet recruiting

Poland,

Centrum Medyczne OMEDICA Site Number: 6160013

Poznań, Poland, 60-111

Not yet recruiting

Poland,

Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017

Lódz, Poland, 90-132

Not yet recruiting

Poland,

Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014

Poznan, Poland, 61-655

Not yet recruiting

Poland,

Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002

Radom, Poland, 26-600

Not yet recruiting

Poland,

ETG Skierniewice - PPDS Site Number: 6160006

Skierniewice, Poland, Lódzkie

Not yet recruiting

Poland,

ETG Lodz Site Number: 6160018

Łódź, Poland, 90-302

Not yet recruiting

Serbia,

Clinical Hospital Centar Zvezdara Site Number: 6880001

Belgrade, Serbia, 11000

Not yet recruiting

Serbia,

University Clinical Center of Serbia - PPDS Site Number: 6880003

Belgrade, Serbia, 11000

Not yet recruiting

Serbia,

University Clinical Center of Serbia - PPDS Site Number: 6880004

Belgrade, Serbia, 11000

Not yet recruiting

Serbia,

University Clinical Center Nis Site Number: 6880002

Niš, Serbia, 18 000

Not yet recruiting

Serbia,

University Clinical Center Nis Site Number: 6880005

Niš, Serbia, 18 000

Not yet recruiting

Serbia,

Health Center Zajecar Site Number: 6880006

Zaječar, Serbia, 19000

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