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 one or more oral glucose-lowering medications. RESEARCH DESIGN AND METHODSThis multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal insulin-treated (total daily dose 10-50 units) people with type 2 diabetes (HbA 1c 7.0-10.0% [53.0-85.8 mmol/mol]) to icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks. Primary end point 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 end points included HbA 1c , adverse events (AEs), and hypoglycemia. RESULTSEstimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n 5 54), 66.0% (icodec NLD; n 5 50), and 65.0% (IGlar U100; n 5 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9%]). Mean HbA 1c 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. CONCLUSIONSSwitching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to onceweekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.

<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_1c 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_1c,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_1c 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>

<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_1c 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_1c,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_1c 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>

<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_1c 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_1c,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_1c 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>