HbA1c Levels and Rates of Hypoglycemia with Insulin Degludec U200 and Insulin Glargine U300 Stratified by Renal Function Subgroups: Post Hoc Analysis from the CONCLUDE Trial

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Key messages

• CONCLUDE was a randomized head-to-head trial comparing insulin degludec 200 units/mL (degludec U200) with insulin glargine 300units/mL (glargine U300) with regard to hypoglycemia risk in insulin experienced people with T2D having at least one risk criterion for hypoglycemia
• No significant difference was observed in the overall symptomatic hypoglycemia rate with degludec U200 versus glargine U300 in the 36-week maintenance period (primary endpoint, tested for superiority). The subsequent hypothesis generating exploratory analyses revealed lower rates of nocturnal symptomatic and severe hypoglycemia during the maintenance period with degludec U200 versus glargine U300.
• The aim of the current post hoc hypothesis-generating analysis was to investigate and compare, between degludec U200 and glargine U300, HbA1c and the above-mentioned hypoglycemia endpoints stratified by estimated baseline renal function.
• Rate ratios for hypoglycemia were consistent with the primary analyses across renal impairment subgroups and there was a trend towards a reduction in HbA1c and total daily insulin dose from baseline with degludec U200 versus glargine U300 irrespective of renal function