TRENT: Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
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 |
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Phase 4 |
Detailed Description
The trial will consist of the following periods:
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A screening period of up to 2 weeks,
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A 24-week, open-label treatment period, including a titration period and a maintenance period.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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 (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)]
- 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)]
- 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)]
- 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]
- 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
Inclusion Criteria:
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Is an adult aged ≥18 years at screening.
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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.
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Has an HbA1c ≥7.5% and ≤10.5% at screening.
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Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.
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Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
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Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
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Is capable of understanding the written informed consent, and provides signed written informed consent.
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Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
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Is willing and able to fast without having administered study drug for scheduled site visits.
Exclusion Criteria:
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Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
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Has a body mass index (BMI)* >45 kg/m² during the screening period.
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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).
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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.
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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 | |
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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.- LPS17007
- 2022-001485-35