Insulin for Type 2 Diabetes

(TRENT Trial)

No longer recruiting at 84 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two types of insulin, Insulin glargine 300 U/mL (Gla-300) and Insulin degludec 100 U/mL (IDeg-100), for individuals with Type 2 Diabetes and kidney issues. The goal is to determine if Gla-300 controls blood sugar as effectively as IDeg-100 without increasing low blood sugar episodes. If Gla-300 performs well, researchers will assess whether it is even more effective at lowering blood sugar levels. This trial targets individuals who have had Type 2 Diabetes for over a year, have not previously used insulin, and are managing their diabetes with oral medications but are not achieving target blood sugar levels. Participants should also have kidney problems and be capable of handling daily life activities. As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

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 is the safety track record for these treatments?

Research has shown that both Insulin glargine 300 U/mL (Gla-300) and Insulin degludec 100 U/mL (IDeg-100) are safe and effective for people with diabetes. Studies indicate that Gla-300 is effective and safe for those new to insulin. In a year-long study, Gla-300 demonstrated a safety record similar to Gla-100, with few side effects.

For IDeg-100, research shows it does not increase the risk of major heart problems in people with type 2 diabetes who already have heart issues. However, like other insulins, it carries a risk of low blood sugar, or hypoglycemia. Both treatments have been widely used, and safety data supports their use in managing blood sugar levels in diabetes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments, Insulin degludec (IDeg-100) and Insulin glargine (Gla-300), because they offer potential advantages for people with Type 2 diabetes who also have renal impairment. Unlike standard insulins, IDeg-100 provides a stable, long-acting effect with less fluctuation in blood sugar levels, which can be especially beneficial for those with compromised kidney function. Gla-300 is similar in offering prolonged blood sugar control but at a lower volume, which may reduce injection site discomfort and improve adherence. Both treatments aim to provide more consistent and manageable blood sugar control compared to existing options, which is why they are generating interest in the medical community.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes Mellitus with renal impairment?

This trial will compare insulin degludec 100 U/mL (IDeg-100) and insulin glargine 300 U/mL (Gla-300) in managing blood sugar levels in people with diabetes. Research has shown that IDeg-100 lowers the risk of nighttime low blood sugar episodes and helps maintain steady blood sugar levels due to its long duration of action. Meanwhile, Gla-300 reduced Hemoglobin A1c, a measure of long-term blood sugar levels, after 24 weeks of use. It also helps control blood sugar without causing weight gain and carries a low risk of severe low blood sugar events. Both treatments are already approved for managing blood sugar in diabetes, demonstrating their effectiveness for this condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9046940/

One-year safety and effectiveness of insulin degludec in ... In the SWITCH-1 study, 100 U/mL insulin degludec resulted in a decreased risk of nocturnal symptomatic hypoglycemia in patients with T1DM ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8565408/

Comparative clinical outcomes of insulin degludec and ... The secondary outcomes were HbA1c reduction (<0.0%), BMI gain (>0.0 kg/m2), and reduction of basal and total insulin doses (>0 units/kg) 6 months after the ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jvim.17303

Insulin degludec 100 U/mL for treatment of spontaneous ... Insulin degludec 100 U/mL is effective for the treatment of dogs with DM. Eighty-four percent (28/33) of dogs responded to once daily dose of IDeg100 with low ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1615692

Efficacy and Safety of Degludec versus Glargine in Type 2 ... The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% ...

5. icer.org icer.org/wp-content/uploads/2020/10/CTAF_Degludec_Final_Report_031416.pdf

Insulin Degludec (Tresiba®, Novo Nordisk A/S) for the ... The long half-life allows for flexible dosing once a day to maintain a steady level in the blood stream. Insulin degludec comes in two formulations: U100, which ...

6. novonordiskmedical.com novonordiskmedical.com/content/dam/medical/novonordiskmedical/documents/safety-data-sheets/Xultophy-SDS-March-2021.pdf

Xultophy® 100/3.6 SDS - Novo Nordisk Medical Contains insulin degludec (100 U/mL) and liraglutide (3.6 mg/mL). Inactive ingredients include: glycerol, metacresol, zinc, hydrochloric acid, ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf

TRESIBA® (insulin degludec) injection, for subcutaneous use TRESIBA is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions (5.3)]. In patients with hypersensitivity to insulin degludec or ...

8. tresiba.com tresiba.com/how-to-take-tresiba/side-effects.html

Tresiba® (insulin degludec injection) 100 Units/mL, 200 ... In a large safety study vs Lantus® in adults with type 2 diabetes and heart disease, Tresiba® did not increase their risk of major cardiovascular events, such ...

9. novomedlink.com novomedlink.com/diabetes/products/treatments/tresiba/efficacy-safety/type-1.html

Tresiba ® (insulin degludec) injection 100 U/mL, 200 U/mL Get Tresiba® (insulin degludec) efficacy and safety information for your patients over 1 year of age with type 1 diabetes. Read Important Safety and ...

10. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1be283d-4b1d-4996-b2a7-4488dbff3037

Label: INSULIN DEGLUDEC injection, solution - DailyMed Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use - • Not recommended ...