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Long-acting Insulin

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

Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study (25 weeks)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial compares two insulin treatments, Gla-300 and IDeg-100, in patients with Type 2 Diabetes who have kidney issues and haven't used insulin before. The goal is to see which insulin better controls blood sugar without increasing the risk of low blood sugar. Gla-300 is a long-acting insulin with improved profiles compared to Gla-100 and IDeg-100.

Eligible Conditions
  • Kidney Failure
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study (25 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (25 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
Secondary study objectives
Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24
+6 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gla-300 armExperimental Treatment1 Intervention
Gla-300 will be administered once daily for 24 weeks
Group II: IDeg-100 armActive Control1 Intervention
Ideg-100 will be administered once daily for 24 weeks

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

SanofiLead Sponsor
2,216 Previous Clinical Trials
4,047,570 Total Patients Enrolled
1 Trials studying Kidney Failure
99 Patients Enrolled for Kidney Failure
~21 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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