Clinical trial NCT05552859: Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Renal Impairment
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period
timeFrame: Baseline to 24 weeks
measure: Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24
timeFrame: At week 24
measure: 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.
timeFrame: Baseline to end of study (25 weeks)
measure: Rate of Hypoglycemia Per Participant-year
timeFrame: Baseline to end of study (25 weeks)]
measure: Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks)
timeFrame: Baseline to end of study (25 weeks)
measure: 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.
timeFrame: Baseline to end of study (25 weeks)
measure: Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
timeFrame: Baseline to end of study (25 weeks)
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Clinical Trials, LLC Site Number: 8400028
state: Arizona
city: Buena Park
country: United States
facility: American Clinical Trials Site Number: 8400014
state: California
city: Canyon Country
country: United States
facility: Clearview Medical Research LLC Site Number: 8400021
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Site Number: 8400003
state: California
city: Santa Clarita
country: United States
facility: Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026
state: California
city: Van Nuys
country: United States
facility: San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023
state: California
city: Waterbury
country: United States
facility: Chase Medical Research LLC Site Number: 8400007
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida Site Number: 8400016
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials Site number: 8400034
state: Florida
city: Miami
country: United States
facility: Wellness Research Center Inc - Miami Site Number: 8400010
state: Florida
city: Miami
country: United States
facility: Med Research of Florida, LLC Investigator Site: 8400033
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research LLC Site Number: 8400004
state: Florida
city: Atlanta
country: United States
facility: Emory University Site Number: 8400032
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC Site Number: 8400001
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Site Number: 8400006
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Clinical Research Site Number: 8400009
state: Georgia
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants Research Center Site Number: 8400031
state: Maryland
city: Las Vegas
country: United States
facility: Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019
state: Nevada
city: New Windsor
country: United States
facility: Mid Hudson Medical Research PLLC Site Number: 8400024
state: New York
city: Morehead City
country: United States
facility: Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008
state: North Carolina
city: Maumee
country: United States
facility: Advanced Medical Research Site Number: 8400012
state: Ohio
city: Newport
country: United States
facility: Capital Area Research LLC Site Number: 8400029
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson University Physicians (JUP) Site Number: 8400025
state: Pennsylvania
city: Bristol
country: United States
facility: Holston Medical Group PC Site Number: 8400018
state: Tennessee
city: El Paso
country: United States
facility: Frontier Medical Center Site Number: 8400035
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC Site Number: 8400017
state: Texas
city: Houston
country: United States
facility: Reichman and Associates Site Number: 8400013
state: Texas
city: Lufkin
country: United States
facility: Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio LLC Site Number: 8400022
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research Site Number: 8400030
state: Texas
city: Suffolk
country: United States
facility: David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005
state: Virginia
city: Krnov
country: Czechia
facility: Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001
state: Moravskoslezský Kraj
city: Olomouc
country: Czechia
facility: Agentura Science Pro spol. s.r.o.Site Number: 2030002
state: Olomoucký Kraj
city: Prague
country: Czechia
facility: Institut Klinicke A Experimentalni Mediciny Site Number: 2030006
state: Praha, Hlavní Mesto
city: Brandýs Nad Labem-Stará Boleslav
country: Czechia
facility: Diacentrum Brandys n. L. Site Number: 2030004
city: Jílové U Prahy
country: Czechia
facility: Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006
state: Szabolcs-Szatmár-Bereg
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház Site Number: 3480001
state: Vas
city: Balatonfüred
country: Hungary
facility: Csolnoky Ferenc Korhaz Site Number: 3480005
state: Veszprém
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz Site Number: 3480002
state: Zala
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ Site Number: 3480003
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004
city: Wroclaw
country: Poland
facility: Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008
state: Lubelskie
city: Puławy
country: Poland
facility: KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010
state: Lubelskie
city: Zamość
country: Poland
facility: KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012
state: Lubelskie
city: Kraków
country: Poland
facility: Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016
state: Malopolskie
city: Radom
country: Poland
facility: Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015
state: Mazowieckie
city: Warszawa
country: Poland
facility: NBR Polska Site Number: 6160003
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW Site Number: 6160005
state: Mazowieckie
city: Gdańsk
country: Poland
facility: NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014
state: Pomorskie
city: Częstochowa
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001
state: Slaskie
city: Lubliniec
country: Poland
facility: Specjalistyczna Praktyka Lekarska Site Number: 6160004
state: Slaskie
city: Staszów
country: Poland
facility: KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011
state: Swietokrzyskie
city: Poznań
country: Poland
facility: Centrum Medyczne OMEDICA Site Number: 6160013
state: Wielkopolskie
city: Lódz
country: Poland
facility: Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017
city: Poznan
country: Poland
facility: Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014
city: Radom
country: Poland
facility: Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002
city: Skierniewice
country: Poland
facility: ETG Skierniewice - PPDS Site Number: 6160006
city: Łódź
country: Poland
facility: ETG Lodz Site Number: 6160018
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara Site Number: 6880001
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - PPDS Site Number: 6880003
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - PPDS Site Number: 6880004
city: Niš
country: Serbia
facility: University Clinical Center Nis Site Number: 6880002
city: Niš
country: Serbia
facility: University Clinical Center Nis Site Number: 6880005
city: Zaječar
country: Serbia
facility: Health Center Zajecar Site Number: 6880006
Study officials:
References: