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Type 2 Diabetes MellitusPhase 4TRENTNCT05552859

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

A Phase 4 study testing Insulin glargine 300 U/mL and Insulin degludec 100 U/mL in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Sanofi at 68 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus, Renal Impairment
What is being tested?
Insulin glargine 300 U/mL and Insulin degludec 100 U/mL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
68 sitesin 5 countries
Study dates
5 Dec 2022to 4 Aug 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

68 sites in 5 countries.

68 sites in 5 countries

United States32 sites

  • Emory University Site Number: 8400032

    Atlanta, Georgia, 30303

  • Agile Clinical Research Trials, LLC Site Number: 8400001

    Atlanta, Georgia, 30328-5532

  • Holston Medical Group PC Site Number: 8400018

    Bristol, Tennessee, 37620-7353

  • American Clinical Trials Site Number: 8400014

    Buena Park, California, 90620-3800

  • Clearview Medical Research LLC Site Number: 8400021

    Canyon Country, California, 91351-4138

  • Innovative Research of West Florida Site Number: 8400016

    Clearwater, Florida, 33756-2004

  • Centricity Research Site Number: 8400006

    Columbus, Georgia, 31904

  • Frontier Medical Center Site Number: 8400035

    El Paso, Texas, 79935-4202

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

    Fort Worth, Texas, 76132-4242

  • Evolution Clinical Trials Site number: 8400034

    Hialeah Gardens, Florida, 33016

  • Juno Research, LLC Site Number: 8400017

    Houston, Texas, 77054

  • Reichman and Associates Site Number: 8400013

    Houston, Texas, 77074-1691

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

    Las Vegas, Nevada, 89113-3628

  • Georgia Clinical Research Site Number: 8400009

    Lawrenceville, Georgia, 30044-5896

  • Torrance Clinical Research Institute Site Number: 8400003

    Lomita, California, 90717-2101

  • Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027

    Lufkin, Texas, 75904-3163

  • Advanced Medical Research Site Number: 8400012

    Maumee, Ohio, 43537-1863

  • Wellness Research Center Inc - Miami Site Number: 8400010

    Miami, Florida, 33135-1601

  • Med Research of Florida, LLC Investigator Site: 8400033

    Miami, Florida, 33186

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

    Morehead City, North Carolina, 28557-3126

  • Mid Hudson Medical Research PLLC Site Number: 8400024

    New Windsor, New York, 12553-7754

  • Capital Area Research LLC Site Number: 8400029

    Newport, Pennsylvania, 17074

  • Florida Institute For Clinical Research LLC Site Number: 8400004

    Orlando, Florida, 32825

  • Jefferson University Physicians (JUP) Site Number: 8400025

    Philadelphia, Pennsylvania, 19107-6810

  • Endocrine and Metabolic Consultants Research Center Site Number: 8400031

    Rockville, Maryland, 20852

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

    Santa Clarita, California, 91321-2454

  • Northeast Clinical Research of San Antonio LLC Site Number: 8400022

    Schertz, Texas, 78154-1403

  • Consano Clinical Research Site Number: 8400030

    Shavano Park, Texas, 78231

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

    Suffolk, Virginia, 23435-3763

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

    Van Nuys, California, 91405-3605

  • Chase Medical Research LLC Site Number: 8400007

    Waterbury, Connecticut, 06708

  • Yuma Clinical Trials, LLC Site Number: 8400028

    Yuma, Arizona, 85364-7110

Other trials in United States

Poland18 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001

    Częstochowa, Silesian Voivodeship, 42-207

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

    Gdansk, Pomeranian Voivodeship, 80-858

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

    Krakow, Lesser Poland Voivodeship, 31-548

  • ETG Lodz Site Number: 6160018

    Lodz, 90-302

  • Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017

    Lódz, 90-132

  • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008

    Lublin, Lublin Voivodeship, 20-538

  • Specjalistyczna Praktyka Lekarska Site Number: 6160004

    Lubliniec, Silesian Voivodeship, 42-700

  • Centrum Medyczne OMEDICA Site Number: 6160013

    Poznan, Greater Poland Voivodeship, 60-111

  • Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014

    Poznan, 61-655

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

    Puławy, Lublin Voivodeship, 24-100

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

    Radom, Masovian Voivodeship, 26-610

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

    Radom, 26-600

  • ETG Skierniewice - PPDS Site Number: 6160006

    Skierniewice, Lódzkie

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

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • NBR Polska Site Number: 6160003

    Warsaw, Masovian Voivodeship, 00-465

  • Centralny Szpital Kliniczny MSW Site Number: 6160005

    Warsaw, Masovian Voivodeship, 02-507

  • Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009

    Wroclaw, Lower Silesian Voivodeship, 50-127

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

    Zamość, Lublin Voivodeship, 22-400

Other trials in Poland

Czechia6 sites

  • Diacentrum Brandys n. L. Site Number: 2030004

    Brandýs nad Labem-Stará Boleslav, 250 01

  • Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005

    Jílové u Prahy, 254 00

  • Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001

    Krnov, Moravian-Silesian Region, 794 01

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

    Olomouc, Olomouc Region, 779 00

  • Institut Klinicke A Experimentalni Mediciny Site Number: 2030006

    Prague, Praha, Hlavní Mesto, 140 21

  • Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007

    Prague, 100 34

Other trials in Czechia

Hungary6 sites

  • Csolnoky Ferenc Korhaz Site Number: 3480005

    Balatonfüred, Veszprém megye, 8230

  • Magyar Honvédség Egészségügyi Központ Site Number: 3480003

    Budapest, 1134

  • Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004

    Kaposvár, 7400

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

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Markusovszky Egyetemi Oktatókórház Site Number: 3480001

    Szombathely, Vas County, 9700

  • Zala Megyei Szent Rafael Korhaz Site Number: 3480002

    Zalaegerszeg, Zala County, 8904

Other trials in Hungary

Serbia6 sites

  • Clinical Hospital Centar Zvezdara Site Number: 6880001

    Belgrade, 11000

  • University Clinical Center of Serbia - PPDS Site Number: 6880003

    Belgrade, 11000

  • University Clinical Center of Serbia - PPDS Site Number: 6880004

    Belgrade, 11000

  • University Clinical Center Nis Site Number: 6880002

    Niš, 18 000

  • University Clinical Center Nis Site Number: 6880005

    Niš, 18 000

  • Health Center Zajecar Site Number: 6880006

    Zaječar, 19000

Other trials in Serbia

About this study

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

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.

Read the 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.
Being tested
Insulin glargine 300 U/mL, Insulin degludec 100 U/mL
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine 300 U/mLDrug

    Also called Toujeo, HOE901-U300

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

  • Insulin degludec 100 U/mLDrug

    Also called Tresiba

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

Study groups in NCT05552859
Study groupRoleWhat they receive
Gla-300 armExperimentalGla-300 will be administered once daily for 24 weeks
Receives: Drug: Insulin glargine 300 U/mL
IDeg-100 armActive comparatorIdeg-100 will be administered once daily for 24 weeks
Receives: Drug: Insulin degludec 100 U/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 24 weeks

Secondary outcomes (9)

  1. 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.

    Measured: Baseline to 24 weeks

  2. 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.

    Measured: Baseline to 24 weeks

  3. 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.

    Measured: Baseline to 24 weeks

  4. 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.

    Measured: At week 24

  5. 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).

    Measured: Baseline to end of study (25 weeks)

  6. Rate of Hypoglycemia Per Participant-year

    Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window)

    Measured: Baseline to end of study (25 weeks)]

  7. 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.

    Measured: Baseline to end of study (25 weeks)

  8. 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]

    Measured: Baseline to end of study (25 weeks)

  9. 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.

    Measured: Baseline to end of study (25 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start5 Dec 2022
  3. Primary completion28 Jul 2023
  4. Study completion4 Aug 2023

Why it stopped: Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552859
Sponsor's protocol ID
LPS17007
Other IDs
2022-001485-35
Acronym
TRENT
Status last verified
Sep 2025
First submitted
7 Sep 2022
Last updated
8 Sep 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine 300 U/mL and Insulin degludec 100 U/mL in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Sanofi at 68 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Poland, Czechia, Hungary, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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