Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment (TRENT)
Study Overview
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.
Study details
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Type 2 Diabetes Mellitus, Renal Impairment
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Age: 18 Years
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Gender: All
Inclusion Criteria:
- Is an adult aged ≥18 years at screening.
- 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.
- Has an HbA1c ≥7.5% and ≤10.5% at screening.
- Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2.
- Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
- Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
- Is capable of understanding the written informed consent, and provides signed written informed consent.
- Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.
- Is willing and able to fast without having administered study drug for scheduled site visits.
Exclusion Criteria:
- Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA.
- Has a body mass index (BMI)* >45 kg/m² during the screening period.
- 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).
- 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.
- 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.