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

(TRENT Trial)

Recruiting at 75 trial locations

Overseen By Clinical Sciences & Operations Study Director

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 4

Sponsor: Sanofi

Must be taking: Oral antidiabetics

Must not be taking: GIP, GLP-1 RA

Disqualifiers: High BMI, Hypoglycemia history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must have been on stable doses of oral antidiabetic drugs for at least 3 months before joining the trial.

What data supports the effectiveness of the drug Insulin degludec 100 U/mL and Insulin glargine 300 U/mL?

Research shows that both Insulin degludec 100 U/mL and Insulin glargine 300 U/mL are effective in managing blood sugar levels in people with type 2 diabetes. Studies like the BRIGHT trial and RESTORE-2 NAIVE STUDY found that these insulins help control blood sugar with similar effectiveness, while also having a comparable safety profile. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Research shows that both insulin degludec and insulin glargine have been studied for safety, particularly in terms of cardiovascular events and hypoglycemia (low blood sugar). These studies suggest that both treatments are generally safe, with similar risks of severe hypoglycemia and cardiovascular issues. ^{3 4 5 6 7}

How do insulin degludec 100 U/mL and insulin glargine 300 U/mL differ from other diabetes drugs?

Insulin degludec 100 U/mL and insulin glargine 300 U/mL are both long-acting insulins used to manage blood sugar levels in diabetes, but they differ in their duration and risk of causing low blood sugar (hypoglycemia). Insulin degludec has a longer duration of action, which may provide more stable blood sugar control, while insulin glargine is designed to release insulin more gradually over time. ^{3 4 5 8 9}

Eligibility Criteria

Inclusion Criteria

Do you have kidney failure?

You are able to use an electronic diary to record your experiences and agree to follow the study's rules.

You haven't used insulin regularly before, except for a short period of less than 15 days in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either Gla-300 or IDeg-100 insulin once daily, including a titration and maintenance period

24 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 phone contact, possible site visit if necessary

Treatment Details

Interventions

• Insulin degludec 100 U/mL
• Insulin glargine 300 U/mL

Participant Groups

Group I: Gla-300 arm Experimental Treatment 1 Intervention

Gla-300 will be administered once daily for 24 weeks

Group II: IDeg-100 arm Active Control 1 Intervention

Ideg-100 will be administered once daily for 24 weeks

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparative effectiveness and safety of glargine 300 U/mL versus degludec 100 U/mL in insulin-naïve patients with type 2 diabetes. A multicenter retrospective real-world study (RESTORE-2 NAIVE STUDY). [2023]

2. England pubmed.ncbi.nlm.nih.gov

Duration of type 2 diabetes does not appear to moderate hypoglycaemia rate with insulin degludec versus insulin glargine U100. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL and insulin degludec 100 U/mL in older participants in the BRIGHT trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Risk of major cardiovascular events, severe hypoglycaemia, and all-cause mortality for users of insulin degludec versus insulin glargine U100-A Danish cohort study. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross-over study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Head-to-Head Comparison of Clinical, Equivalent Doses of Insulin Glargine 300 units · mL-1 and Insulin Degludec 100 units · mL-1 in Type 1 Diabetes. [2022]