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

Stopped early · Phase 4

Conditions studied: Type 2 Diabetes Mellitus, Renal Impairment

In brief

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.

Key facts

Study ID

NCT05552859

Run by

Sanofi

People needed

62

Starts

2022-12-05

Expected to finish

2023-08-04

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• American Clinical Trials Site Number: 8400014 — Buena Park, California, United States
• Clearview Medical Research LLC Site Number: 8400021 — Canyon Country, California, United States
• Torrance Clinical Research Institute Site Number: 8400003 — Lomita, California, United States
• Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026 — Santa Clarita, California, United States
• San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023 — Van Nuys, California, United States
• Chase Medical Research LLC Site Number: 8400007 — Waterbury, Connecticut, United States
• Innovative Research of West Florida Site Number: 8400016 — Clearwater, Florida, United States
• Evolution Clinical Trials Site number: 8400034 — Hialeah Gardens, Florida, United States
• Wellness Research Center Inc - Miami Site Number: 8400010 — Miami, Florida, United States
• Med Research of Florida, LLC Investigator Site: 8400033 — Miami, Florida, United States
• Florida Institute For Clinical Research LLC Site Number: 8400004 — Orlando, Florida, United States
• ETG Lodz Site Number: 6160018 — Lodz, Poland
• Emory University Site Number: 8400032 — Atlanta, Georgia, United States
• Agile Clinical Research Trials, LLC Site Number: 8400001 — Atlanta, Georgia, United States
• Centricity Research Site Number: 8400006 — Columbus, Georgia, United States
• Georgia Clinical Research Site Number: 8400009 — Lawrenceville, Georgia, United States
• Endocrine and Metabolic Consultants Research Center Site Number: 8400031 — Rockville, Maryland, United States
• Diabetes, Obesity, Cardiovascular Clinical Specialists (DOCS) Site Number: 8400019 — Las Vegas, Nevada, United States
• Mid Hudson Medical Research PLLC Site Number: 8400024 — New Windsor, New York, United States
• Lucas Research - Morehead City - HyperCore - PPDS Site Number: 8400008 — Morehead City, North Carolina, United States
• Advanced Medical Research Site Number: 8400012 — Maumee, Ohio, United States
• Capital Area Research LLC Site Number: 8400029 — Newport, Pennsylvania, United States
• Jefferson University Physicians (JUP) Site Number: 8400025 — Philadelphia, Pennsylvania, United States
• Holston Medical Group PC Site Number: 8400018 — Bristol, Tennessee, United States
• Yuma Clinical Trials, LLC Site Number: 8400028 — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.