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Long-acting Insulin

Gla-300 arm for Type 2 Diabetes (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

TRENT Trial Summary

This trial is designed to compare the efficacy and safety of two diabetes treatments, Gla-300 and IDeg-100, in insulin-naïve patients with Type 2 Diabetes Mellitus and renal impairment. The hypothesis is that Gla-300 is non-inferior to IDeg-100 in terms of glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in terms of reducing Hemoglobin A1c levels, without an increased potential risk of hypoglycemia.

Eligible Conditions
  • Type 2 Diabetes
  • Kidney Failure
  • Diabetes

TRENT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gamma-linolenic acid
Secondary outcome measures
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

TRENT 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
2,163 Previous Clinical Trials
3,512,418 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for participants in this clinical trial?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial, which was initially posted on October 7th 2022, is enrolling patients currently. 630 individuals are expected to partake from 27 distinct sites."

Answered by AI

What is the geographical scope of this research trial?

"This trial is being carried out across a variety of medical sites. For example, Advanced Medical Research Site Number: 8400012 in Maumee, Florida Institute For Clinical Research LLC Site Number: 8400004 in Orlando and Endocrine Consultants Research - Columbus - IACT - HyperCore - PPDS Site Number: 8400006 in Columbus are among the 27 participating centres."

Answered by AI

What safety parameters have been observed when administering the Gla-300 arm to patients?

"Gla-300 arm recieved a score of 3 due to it being in Phase 4 trials, indicating that this treatment has already been approved."

Answered by AI

Are there still slots available for this experiment to include participants?

"Affirmative. According to the clinical trial data on clinicaltrials.gov, this research project has been ongoing since October 7th 2022 and was last revised on November 14th 2022; 630 participants are needed at 27 separate medical sites across the country."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Other
Georgia
Arizona
What site did they apply to?
Agile Clinical Research Trials, LLC Site Number: 8400001
Other
Emory University Site Number: 8400032
Yuma Clinical Trials, LLC Site Number: 8400028
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

Yes I live in yuma. To see what's out there. To see if it works for me. Learn more about the trial.
PatientReceived 1 prior treatment
want to get rid of ty[e 2 now!
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Length of screening test? How much do we get paid for this??
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Yuma Clinical Trials, LLC Site Number: 8400028: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
2022. "Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05552859.
~27 spots leftby Apr 2025
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