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

Conditions

• Renal Impairment
• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin glargine 300 U/mL — DRUG
  Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
• Insulin degludec 100 U/mL — DRUG
  Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.

Study Details

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 Dates

Start date

Dec 5, 2022

Status verified

Sep 2025

Primary completion

Jul 28, 2023

Completion

Aug 4, 2023

Study Design

Enrollment

62 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gla-300 arm
  Gla-300 will be administered once daily for 24 weeks
• Active Comparator: IDeg-100 arm
  Ideg-100 will be administered once daily for 24 weeks

Primary Outcome Measure

Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) [ Time Frame: Baseline to 24 weeks ]

Locations (32)

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