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

Primary Purpose

Type 2 Diabetes Mellitus, Renal Impairment

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Insulin glargine 300 U/mL

Insulin degludec 100 U/mL

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yuma Clinical Trials, LLC Site Number: 8400028
American Clinical Trials Site Number: 8400014
Clearview Medical Research LLC Site Number: 8400021
Torrance Clinical Research Institute Site Number: 8400003
Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026
San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023
Chase Medical Research LLC Site Number: 8400007
Innovative Research of West Florida Site Number: 8400016
Evolution Clinical Trials Site number: 8400034
Wellness Research Center Inc - Miami Site Number: 8400010
Med Research of Florida, LLC Investigator Site: 8400033
Florida Institute For Clinical Research LLC Site Number: 8400004
Emory University Site Number: 8400032
Agile Clinical Research Trials, LLC Site Number: 8400001
Centricity Research Site Number: 8400006
Georgia Clinical Research Site Number: 8400009
Endocrine and Metabolic Consultants Research Center Site Number: 8400031
Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019
Mid Hudson Medical Research PLLC Site Number: 8400024
Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008
Advanced Medical Research Site Number: 8400012
Capital Area Research LLC Site Number: 8400029
Jefferson University Physicians (JUP) Site Number: 8400025
Holston Medical Group PC Site Number: 8400018
Frontier Medical Center Site Number: 8400035
Diabetes and Thyroid Center of Fort Worth PLLC Site Number: 8400015
Juno Research, LLC Site Number: 8400017
Reichman and Associates Site Number: 8400013
Texas Institute for Kidney and Endocrine Disorders Site Number: 8400027
Northeast Clinical Research of San Antonio LLC Site Number: 8400022
Consano Clinical Research Site Number: 8400030
David Ramstad Associates Research - IACT - HyperCore - PPDS Site Number: 8400005
Diabetologie MUDr. Tomas Edelsberger Site Number: 2030001
Agentura Science Pro spol. s.r.o.Site Number: 2030002
Institut Klinicke A Experimentalni Mediciny Site Number: 2030006
Diacentrum Brandys n. L. Site Number: 2030004
Diabetologicka, interni a obezitologicka ambulance Site Number: 2030005
Fakultni nemocnice Kralovske Vinohrady Site Number: 2030007
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Site Number: 3480006
Markusovszky Egyetemi Oktatókórház Site Number: 3480001
Csolnoky Ferenc Korhaz Site Number: 3480005
Zala Megyei Szent Rafael Korhaz Site Number: 3480002
Magyar Honvédség Egészségügyi Központ Site Number: 3480003
Somogy Megyei Kaposi Mór Oktató Kórház Site Number: 3480004
Regionalna Poradnia Diabetologiczna - Wroclaw Site Number: 6160009
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna Medica Site Number: 6160008
KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160010
KO-MED Centra Kliniczne Sp. z o.o. Site Number: 6160012
Zaklad Opieki Medycznej "Sanatio" Sp.z o.o. - Osrodek Leczenia Schorzen Cywilizacyjnych Site Number: 6160016
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Site Number: 6160015
NBR Polska Site Number: 6160003
Centralny Szpital Kliniczny MSW Site Number: 6160005
NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o. Site Number: 6160014
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Site Number: 6160001
Specjalistyczna Praktyka Lekarska Site Number: 6160004
KO-MED Centra Kliniczne Sp. z o.o. Site Number:6160011
Centrum Medyczne OMEDICA Site Number: 6160013
Gabinet Lekarski Malgorzata Saryusz-Wolska Site Number: 6160017
Praktyka Lekarska Ewa Krzyzagórska Site Number: 6160014
Prywatny Gabinet Lekarski, Centrum Medyczne "Diabetika" Site Number:6160002
ETG Skierniewice - PPDS Site Number: 6160006
ETG Lodz Site Number: 6160018
Clinical Hospital Centar Zvezdara Site Number: 6880001
University Clinical Center of Serbia - PPDS Site Number: 6880003
University Clinical Center of Serbia - PPDS Site Number: 6880004
University Clinical Center Nis Site Number: 6880002
University Clinical Center Nis Site Number: 6880005
Health Center Zajecar Site Number: 6880006

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gla-300 arm

IDeg-100 arm

Arm Description

Gla-300 will be administered once daily for 24 weeks

Ideg-100 will be administered once daily for 24 weeks

Outcomes

Primary Outcome Measures

Difference in the mean change from baseline to Week 24 in HbA1c level (Gla-300 vs IDeg-100)

Secondary Outcome Measures

Change in Fasting Plasma Glucose (FPG) from baseline to Week 24

Change in fasting Self-Measured Plasma Glucose (SMPG) from baseline to Week 24

Change in 7-point SMPG profiles from baseline to Week 24, per time point within 24-hour period

Percentage of participants reaching HbA1c target of <7.0% at Week 24

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.

Rate of hypoglycemia per participant-year computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window).

Percentage of participants and event rate of hypoglycemia by trial period (for ≤12 weeks, for >12 weeks to ≤24 weeks)

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.

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

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

Full Information

NCT ID

NCT05552859

First Posted

September 7, 2022

Last Updated

September 1, 2023

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT05552859

Brief Title

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

Acronym

TRENT

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

December 5, 2022 (Actual)

Primary Completion Date

July 28, 2023 (Actual)

Study Completion Date

August 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gla-300 arm

Arm Type

Experimental

Arm Description

Gla-300 will be administered once daily for 24 weeks

Arm Title

IDeg-100 arm

Arm Type

Active Comparator

Arm Description

Ideg-100 will be administered once daily for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Insulin glargine 300 U/mL

Other Intervention Name(s)

Toujeo, HOE901-U300

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin degludec 100 U/mL

Other Intervention Name(s)

Tresiba

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in the mean change from baseline to Week 24 in HbA1c level (Gla-300 vs IDeg-100)

Time Frame

Baseline to 24 weeks

Secondary Outcome Measure Information:

Title

Change in Fasting Plasma Glucose (FPG) from baseline to Week 24

Time Frame

Baseline to 24 weeks

Title

Change in fasting Self-Measured Plasma Glucose (SMPG) from baseline to Week 24

Time Frame

Baseline to 24 weeks

Title

Change in 7-point SMPG profiles from baseline to Week 24, per time point within 24-hour period

Time Frame

Baseline to 24 weeks

Title

Percentage of participants reaching HbA1c target of <7.0% at Week 24

Time Frame

At week 24

Title

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.

Time Frame