Insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) have shown slightly different pharmacokinetic/pharmacodynamic profiles; however, the first head-to-head randomised controlled trial in insulin-naïve people with type 2 diabetes (T2D) demonstrated similarity in clinical endpoints, except during the 0–12 week period when results were in favour of Gla-300 for anytime hypoglycaemia.
InRange aims to assess the clinical impact of Gla-300 and IDeg-100 in people with T1D by assessing primarily continuous glucose monitoring (CGM) endpoints.
Approximately 340 people with T1D aged 18–70 years, on a basal + mealtime insulin regimen for ≥1 year, and HbA1c ≥7 % and <10 % will be included. Screening (1–2 weeks) will be followed by a 4-week run-in (background insulin treatment optimisation including 2-weeks baseline CGM) and a 12-week randomised treatment period after basal insulin switch to Gla-300 or IDeg-100 (titrated to the target glucose range without hypoglycaemia). During the randomised period, CGM will be performed at weeks 11–12 according to the most recent CGM consensus statement and ADA guidelines. The primary endpoint will be analysed using a mixed-effect model with repeated measures approach.
Study ongoing
The objectives are to assess the percentage time in range for glucose (70–180 mg/dL [3.9–10 mmol/L]) (primary endpoint) at week 12, and glucose variability (reported as coefficient of variation [total, within day, between day]); in addition to other clinical outcomes including occurrence and frequency of hypoglycaemia (severe; documented symptomatic; and asymptomatic (<70 mg/dL [<3.9 mmol/L], <54 mg/dL [<3.0 mmol/L])).
Supported by:Sanofi, EudraCT: 2017-002756-91; NCT04075513