<b>OBJECTIVE</b><br><b></b><p><b>
</b>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.</p>
<p><b>RESEARCH DESIGN AND METHODS</b><br>
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 (HbA<sub>1c</sub>
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 <a>range (TIR; 3.9–10.0 mmol/L [70–180 mg/dL]) </a>during
weeks 15 and 16, measured using continuous glucose monitoring. Key secondary endpoints
included HbA<sub>1c</sub>,<sub> </sub>adverse events (AEs) and hypoglycemia. </p>
<p><b>RESULTS</b><br>
Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; <i>n</i> = 54),
66.0% (icodec NLD; <i>n</i> = 50) and 65.0% (IGlar U100; <i>n</i> = 50), with a
statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points,
95% CI 1.8 to 13.9%). Mean HbA<sub>1c</sub> 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.<br>
<br>
</p>
<p><b>CONCLUSIONS</b><br>
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.</p>