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

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.