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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Yuma Clinical Trials, LLC Site Number: 8400028
Yuma, Arizona, United States
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
Start Date
December 5, 2022
Primary Completion Date
July 28, 2023
Completion Date
August 4, 2023
Last Updated
September 8, 2025
62
ACTUAL participants
Insulin glargine 300 U/mL
DRUG
Insulin degludec 100 U/mL
DRUG
Lead Sponsor
Sanofi
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861