Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial
Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine U100 (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and ≥1 oral glucose-lowering medication.
RESEARCH DESIGN AND METHODS
This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible
basal-insulin-treated (total daily dose 10–50 U) people with type 2 diabetes (HbA1c
7.0–10.0% [53.0–13.3 mmol/mo]) to icodec with an initial 100% loading dose
(where only the first dose was doubled; icodec LD), icodec with no loading dose
(icodec NLD) or IGlar U100 for 16 weeks. Primary endpoint was percent time
in range (TIR; 3.9–10.0 mmol/L [70–180 mg/dL]) during
weeks 15 and 16, measured using continuous glucose monitoring. Key secondary endpoints
included HbA1c, adverse events (AEs) and hypoglycemia.
RESULTS
Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n = 54),
66.0% (icodec NLD; n = 50) and 65.0% (IGlar U100; n = 50), with a
statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points,
95% CI 1.8 to 13.9%). Mean HbA1c reduced from 7.9% (62.8 mmol/mol) at
baseline to 7.1% ([54.4 mmol/mol] icodec LD) and 7.4% ([57.6 mmol/mol] icodec
NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were
comparable.
CONCLUSIONS
Switching from daily basal insulin to once-weekly icodec was well tolerated and
provided effective glycemic control. Loading dose use when switching to once-weekly
icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily
IGlar U100, without increasing hypoglycemia risk.