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

NCT05552859 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-09-08

Study results available
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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.

Conditions

Interventions

DRUG

Insulin glargine 300 U/mL

Insulin glargine 300 U/mL in the SoloStar pen, self-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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2023-07-28
Completion
2023-08-04
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Hungary
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552859 on ClinicalTrials.gov