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

NCT05552859 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: LPS170072022-001485-35
• Study Type: interventional
• Target: 62
• Locations: 5 countries
• Sites: 68

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.

Conditions

Type 2 Diabetes Mellitus; Renal Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

  Baseline to 24 weeks

• Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24

  Baseline to 24 weeks

• Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period

  Baseline to 24 weeks

• Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24

  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.

  Baseline to end of study (25 weeks)

Study Arms (2)

Gla-300 arm

EXPERIMENTAL

Gla-300 will be administered once daily for 24 weeks

Drug: Insulin glargine 300 U/mL

IDeg-100 arm

ACTIVE COMPARATOR

Ideg-100 will be administered once daily for 24 weeks

Drug: Insulin degludec 100 U/mL

Interventions

Insulin glargine 300 U/mL DRUG

Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.

Also known as: Toujeo, HOE901-U300

Gla-300 arm

Insulin degludec 100 U/mL DRUG

Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.

Also known as: Tresiba

IDeg-100 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (68)

Yuma Clinical Trials, LLC Site Number: 8400028

Yuma, Arizona, 85364-7110, United States

Location

American Clinical Trials Site Number: 8400014

Buena Park, California, 90620-3800, United States

Location

Clearview Medical Research LLC Site Number: 8400021

Canyon Country, California, 91351-4138, United States

Location

Torrance Clinical Research Institute Site Number: 8400003

Lomita, California, 90717-2101, United States

Location

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

Santa Clarita, California, 91321-2454, United States

Location

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

Van Nuys, California, 91405-3605, United States

Location

Chase Medical Research LLC Site Number: 8400007

Waterbury, Connecticut, 06708, United States

Location

Innovative Research of West Florida Site Number: 8400016

Clearwater, Florida, 33756-2004, United States

Location

Evolution Clinical Trials Site number: 8400034

Hialeah Gardens, Florida, 33016, United States

Location

Wellness Research Center Inc - Miami Site Number: 8400010

Miami, Florida, 33135-1601, United States

Location

Med Research of Florida, LLC Investigator Site: 8400033

Miami, Florida, 33186, United States

Location

Florida Institute For Clinical Research LLC Site Number: 8400004

Orlando, Florida, 32825, United States

Location

Emory University Site Number: 8400032

Atlanta, Georgia, 30303, United States

Location

Agile Clinical Research Trials, LLC Site Number: 8400001

Atlanta, Georgia, 30328-5532, United States

Location

Centricity Research Site Number: 8400006

Columbus, Georgia, 31904, United States

Location

Georgia Clinical Research Site Number: 8400009

Lawrenceville, Georgia, 30044-5896, United States

Location

Endocrine and Metabolic Consultants Research Center Site Number: 8400031

Rockville, Maryland, 20852, United States

Location

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

Las Vegas, Nevada, 89113-3628, United States

Location

Mid Hudson Medical Research PLLC Site Number: 8400024

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

Location

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

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

Location

Advanced Medical Research Site Number: 8400012

Maumee, Ohio, 43537-1863, United States

Location

Capital Area Research LLC Site Number: 8400029

Newport, Pennsylvania, 17074, United States

Location

Jefferson University Physicians (JUP) Site Number: 8400025

Philadelphia, Pennsylvania, 19107-6810, United States

Location

Holston Medical Group PC Site Number: 8400018

Bristol, Tennessee, 37620-7353, United States

Location

Frontier Medical Center Site Number: 8400035

El Paso, Texas, 79935-4202, United States

Location

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

Fort Worth, Texas, 76132-4242, United States

Location

Juno Research, LLC Site Number: 8400017

Houston, Texas, 77054, United States

Location

Reichman and Associates Site Number: 8400013

Houston, Texas, 77074-1691, United States

Location

Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027

Lufkin, Texas, 75904-3163, United States

Location

Northeast Clinical Research of San Antonio LLC Site Number: 8400022

Schertz, Texas, 78154-1403, United States

Location

Consano Clinical Research Site Number: 8400030

Shavano Park, Texas, 78231, United States

Location

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

Suffolk, Virginia, 23435-3763, United States

Location

Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001

Krnov, Moravskoslezský kraj, 794 01, Czechia

Location

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

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Institut Klinicke A Experimentalni Mediciny Site Number: 2030006

Prague, Praha, Hlavní Mesto, 140 21, Czechia

Location

Diacentrum Brandys n. L. Site Number: 2030004

Brandýs nad Labem-Stará Boleslav, 250 01, Czechia

Location

Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005

Jílové u Prahy, 254 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007

Prague, 100 34, Czechia

Location

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

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Markusovszky Egyetemi Oktatókórház Site Number: 3480001

Szombathely, Vas County, 9700, Hungary

Location

Csolnoky Ferenc Korhaz Site Number: 3480005

Balatonfüred, Veszprém megye, 8230, Hungary

Location

Zala Megyei Szent Rafael Korhaz Site Number: 3480002

Zalaegerszeg, Zala County, 8904, Hungary

Location

Magyar Honvédség Egészségügyi Központ Site Number: 3480003

Budapest, 1134, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004

Kaposvár, 7400, Hungary

Location

Centrum Medyczne OMEDICA Site Number: 6160013

Poznan, Greater Poland Voivodeship, 60-111, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-548, Poland

Location

Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009

Wroclaw, Lower Silesian Voivodeship, 50-127, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008

Lublin, Lublin Voivodeship, 20-538, Poland

Location

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

Puławy, Lublin Voivodeship, 24-100, Poland

Location

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

Zamość, Lublin Voivodeship, 22-400, Poland

Location

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

Radom, Masovian Voivodeship, 26-610, Poland

Location

NBR Polska Site Number: 6160003

Warsaw, Masovian Voivodeship, 00-465, Poland

Location

Centralny Szpital Kliniczny MSW Site Number: 6160005

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-858, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001

Częstochowa, Silesian Voivodeship, 42-207, Poland

Location

Specjalistyczna Praktyka Lekarska Site Number: 6160004

Lubliniec, Silesian Voivodeship, 42-700, Poland

Location

ETG Lodz Site Number: 6160018

Lodz, 90-302, Poland

Location

Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017

Lódz, 90-132, Poland

Location

Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014

Poznan, 61-655, Poland

Location

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

Radom, 26-600, Poland

Location

ETG Skierniewice - PPDS Site Number: 6160006

Skierniewice, Lódzkie, Poland

Location

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

Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

Location

Clinical Hospital Centar Zvezdara Site Number: 6880001

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia - PPDS Site Number: 6880003

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia - PPDS Site Number: 6880004

Belgrade, 11000, Serbia

Location

University Clinical Center Nis Site Number: 6880002

Niš, 18 000, Serbia

Location

University Clinical Center Nis Site Number: 6880005

Niš, 18 000, Serbia

Location

Health Center Zajecar Site Number: 6880006

Zaječar, 19000, Serbia

Location

Related Links

• LPS17007 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Interventions

Insulin Glargine; insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The sponsor made the strategic decision to discontinue the trial due to a significant recruitment delay (ie, the number of randomized participants remained significantly lower \[\<10% than originally planned sample size\]). No safety signals were detected during the trial, and the trial team remained blinded to the data collected for the randomized participants at the time of early discontinuation of the trial.

Results Point of Contact

• Title: Trial Transparency email recommended (Toll free for US & Canada)
• Organization: Sanofi

Contact-us@sanofi.com

800-633-1610

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 23, 2022
• Study Start: December 5, 2022
• Primary Completion: July 28, 2023
• Study Completion: August 4, 2023
• Last Updated: September 8, 2025
• Results First Posted: September 5, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CZ (6); US (32); PL (18); HU (6); SE (6)