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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05552859
Collaborator
(none)
630
63
2
15.3
10
0.7

Study Details

Study Description

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 Intervention/Treatment Phase
  • Drug: Insulin glargine 300 U/mL
  • Drug: Insulin degludec 100 U/mL
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 Design

Study Type:
Interventional
Anticipated Enrollment :
630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 :
Dec 5, 2022
Anticipated Primary Completion Date :
Mar 7, 2024
Anticipated Study Completion Date :
Mar 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gla-300 arm

Gla-300 will be administered once daily for 24 weeks

Drug: Insulin glargine 300 U/mL
Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
Other Names:
  • Toujeo
  • HOE901-U300
  • Active Comparator: IDeg-100 arm

    Ideg-100 will be administered once daily for 24 weeks

    Drug: Insulin degludec 100 U/mL
    Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.
    Other Names:
  • Tresiba
  • Outcome Measures

    Primary Outcome Measures

    1. Difference in the mean change from baseline to Week 24 in HbA1c level (Gla-300 vs IDeg-100) [Baseline to 24 weeks]

    Secondary Outcome Measures

    1. Change in Fasting Plasma Glucose (FPG) from baseline to Week 24 [Baseline to 24 weeks]

    2. Change in fasting Self-Measured Plasma Glucose (SMPG) from baseline to Week 24 [Baseline to 24 weeks]

    3. Change in 7-point SMPG profiles from baseline to Week 24, per time point within 24-hour period [Baseline to 24 weeks]

    4. Percentage of participants reaching HbA1c target of <7.0% at Week 24 [At week 24]

    5. Percentage of participants with ≥1 episode(s) of confirmed hypoglycemia (cut-off value 70 mg/dL and 54 mg/dL) and event rate during the 24-week treatment period. [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). [Baseline to end of study (25 weeks)]

    7. Percentage of participants and event rate of hypoglycemia by trial period (for ≤12 weeks, for >12 weeks to ≤24 weeks) [Baseline to end of study (25 weeks)]

    8. The 24-hour (all time), daytime, and nocturnal (00:00 to 05:59, both inclusive) distribution of the occurrence of each episode of documented hypoglycemia by category, presented by 2-hour timeframe over 24 hours during the 24-week treatment period. [Baseline to end of study (25 weeks)]

      Hypoglycemia Categories [(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification]

    9. Number of participants with adverse events (AEs)) and serious adverse events (SAEs), including adverse events of special interest (AESIs) [Baseline to end of study (25 weeks)]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Is an adult aged ≥18 years at screening.

    2. 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.

    3. Has an HbA1c ≥7.5% and ≤10.5% at screening.

    4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.

    5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.

    6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.

    7. Is capable of understanding the written informed consent, and provides signed written informed consent.

    8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.

    9. Is willing and able to fast without having administered study drug for scheduled site visits.

    Exclusion Criteria:
    1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.

    2. Has a body mass index (BMI)* >45 kg/m² during the screening period.

    3. 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).

    4. 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.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yuma Clinical Trials, LLC Site Number: 8400028 Yuma Arizona United States 85364-7110
    2 American Clinical Trials Site Number: 8400014 Buena Park California United States 90620-3800
    3 Clearview Medical Research LLC Site Number: 8400021 Canyon Country California United States 91351-4138
    4 Torrance Clinical Research Institute Site Number: 8400003 Lomita California United States 90717-2101
    5 Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026 Santa Clarita California United States 91321-2454
    6 San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023 Van Nuys California United States 91405-3605
    7 Chase Medical Research LLC Site Number: 8400007 Waterbury Connecticut United States 06708
    8 Innovative Research of West Florida Site Number: 8400016 Clearwater Florida United States 33756-2004
    9 Wellness Research Center Inc - Miami Site Number: 8400010 Miami Florida United States 33135-1601
    10 Floridian Research Institute Site Investigator Site: 8400011 Miami Florida United States 33179-2537
    11 Med Research of Florida, LLC Investigator Site: 8400033 Miami Florida United States 33186
    12 Florida Institute For Clinical Research LLC Site Number: 8400004 Orlando Florida United States 32825
    13 Agile Clinical Research Trials, LLC Site Number: 8400001 Atlanta Georgia United States 30328-5532
    14 Endocrine Consultants Research - Columbus - IACT - HyperCore - PPDS Site Number: 8400006 Columbus Georgia United States 31904-4501
    15 Georgia Clinical Research Site Number: 8400009 Lawrenceville Georgia United States 30044-5896
    16 John H. Stroger Jr. Hospital of Cook County Site Number: 8400002 Chicago Illinois United States 60612-3723
    17 Capital Diabetes & Endocrine Associates - Camp Springs Site Number: 8400020 Suitland Maryland United States 20746-4518
    18 Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019 Las Vegas Nevada United States 89113-3628
    19 Mid Hudson Medical Research PLLC Site Number: 8400024 New Windsor New York United States 12553-7754
    20 Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008 Morehead City North Carolina United States 28557-3126
    21 Advanced Medical Research Site Number: 8400012 Maumee Ohio United States 43537-1863
    22 Jefferson University Physicians (JUP) Site Number: 8400025 Philadelphia Pennsylvania United States 19107-6810
    23 Holston Medical Group PC Site Number: 8400018 Bristol Tennessee United States 37620-7353
    24 Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015 Fort Worth Texas United States 76132-4242
    25 Juno Research, LLC Site Number: 8400017 Houston Texas United States 77054
    26 Reichman and Associates Site Number: 8400013 Houston Texas United States 77074-1691
    27 Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027 Lufkin Texas United States 75904-3163
    28 Northeast Clinical Research of San Antonio LLC Site Number: 8400022 Schertz Texas United States 78154-1403
    29 David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005 Suffolk Virginia United States 23435-3763
    30 Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001 Krnov Moravskoslezský Kraj Czechia 794 01
    31 Agentura Science Pro spol. s.r.o.Site Number: 2030002 Olomouc Olomoucký Kraj Czechia 779 00
    32 Institut Klinicke A Experimentalni Mediciny Site Number: 2030006 Prague Praha, Hlavní Mesto Czechia 140 21
    33 Diacentrum Brandys n. L. Site Number: 2030004 Brandýs Nad Labem-Stará Boleslav Czechia 250 01
    34 Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005 Jílové U Prahy Czechia 254 00
    35 Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007 Praha Czechia 100 34
    36 Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006 Nyíregyháza Szabolcs-Szatmár-Bereg Hungary 4400
    37 Markusovszky Egyetemi Oktatókórház Site Number: 3480001 Szombathely Vas Hungary 9700
    38 Csolnoky Ferenc Korhaz Site Number: 3480005 Balatonfüred Veszprém Hungary 8230
    39 Zala Megyei Szent Rafael Korhaz Site Number: 3480002 Zalaegerszeg Zala Hungary 8904
    40 Magyar Honvédség Egészségügyi Központ Site Number: 3480003 Budapest Hungary 1134
    41 Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004 Kaposvár Hungary 7400
    42 Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009 Wroclaw Dolnoslaskie Poland 50-127
    43 Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008 Lublin Lubelskie Poland 20-538
    44 KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010 Puławy Lubelskie Poland 24-100
    45 KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012 Zamość Lubelskie Poland 22-400
    46 Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016 Kraków Malopolskie Poland 31-548
    47 Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015 Radom Mazowieckie Poland 26-610
    48 NBR Polska Site Number: 6160003 Warszawa Mazowieckie Poland 00-465
    49 Centralny Szpital Kliniczny MSW Site Number: 6160005 Warszawa Mazowieckie Poland 02-507
    50 NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014 Gdańsk Pomorskie Poland 80-858
    51 NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001 Częstochowa Slaskie Poland 42-207
    52 Specjalistyczna Praktyka Lekarska Site Number: 6160004 Lubliniec Slaskie Poland 42-700
    53 KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011 Staszów Swietokrzyskie Poland 28-200
    54 Centrum Medyczne OMEDICA Site Number: 6160013 Poznań Wielkopolskie Poland 60-111
    55 Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014 Poznan Poland 61-655
    56 Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002 Radom Poland 26-600
    57 ETG Skierniewice - PPDS Site Number: 6160006 Skierniewice Poland Lódzkie
    58 Clinical Hospital Centar Zvezdara Site Number: 6880001 Belgrade Serbia 11000
    59 University Clinical Center of Serbia - PPDS Site Number: 6880003 Belgrade Serbia 11000
    60 University Clinical Center of Serbia - PPDS Site Number: 6880004 Belgrade Serbia 11000
    61 University Clinical Center Nis Site Number: 6880002 Niš Serbia 18 000
    62 University Clinical Center Nis Site Number: 6880005 Niš Serbia 18 000
    63 Health Center Zajecar Site Number: 6880006 Zaječar Serbia 19000

    Sponsors and Collaborators

    • Sanofi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT05552859
    Other Study ID Numbers:
    • LPS17007
    • 2022-001485-35
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Dec 16, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2022