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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Renal Impairment; Type 2 Diabetes Mellitus

Treatments: Drug: Insulin degludec 100 U/mL; Drug: Insulin glargine 300 U/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552859

LPS17007

2022-001485-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The trial will consist of the following periods:

• A screening period of up to 2 weeks,
• A 24-week, open-label treatment period, including a titration period and a maintenance period.
• A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is an adult aged ≥18 years at screening.
2. Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of >1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period.
3. Has an HbA1c ≥7.5% and ≤10.5% at screening.
4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.
5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
7. Is capable of understanding the written informed consent, and provides signed written informed consent.
8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
9. Is willing and able to fast without having administered study drug for scheduled site visits.

Exclusion criteria

1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
2. Has a body mass index (BMI)* >45 kg/m² during the screening period.
3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels).
4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening.
5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Gla-300 arm

Experimental group

Description:

Gla-300 will be administered once daily for 24 weeks

Treatment:

Drug: Insulin glargine 300 U/mL

IDeg-100 arm

Active Comparator group

Description:

Ideg-100 will be administered once daily for 24 weeks

Treatment:

Drug: Insulin degludec 100 U/mL