Insulin icodec is a novel once-weekly basal insulin analog. This trial investigated the efficacy and safety of icodec using different once-weekly titration algorithms. RESEARCH DESIGN AND METHODSThis was a phase 2, randomized, open-label, 16-week, treat-to-target study. Insulin-naïve adults (n 5 205) with type 2 diabetes and HbA 1c 7-10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (prebreakfast self-measured blood glucose target 80-130 mg/dL; adjustment ±21 units/week; n 5 51), B (80-130 mg/dL; ±28 units/week; n 5 51), or C (70-108 mg/dL; ±28 units/week; n 5 52), or once-daily insulin glargine U100 (IGlar U100) (80-130 mg/dL; ±4 units/day; n 5 51), all titrated weekly. Percentage of time in range (TIR) (70-180 mg/dL) during weeks 15 and 16 was measured using continuous glucose monitoring.

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<b>OBJECTIVE</b> <p>Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated the efficacy and safety of icodec using different once-weekly titration algorithms.</p> <p><b>RESEARCH DESIGN AND METHODS</b></p> <p>This was a phase 2, randomized, open-label, 16-week, treat-to-target study. Insulin-naïve adults (<i>n</i> = 205) with type 2 diabetes and HbA1c 7–10% while treated with oral glucose-lowering medications initiated once-weekly icodec titrations A (pre-breakfast self-measured blood glucose target, 80–130 mg/dL; adjustment ±21U/week; <i>n</i> = 51), B (80–130 mg/dL; ±28U/week; <i>n</i> = 51), C (70–108 mg/dL; ±28U/week; <i>n</i> = 52), or once-daily insulin glargine U100 (IGlar U100; 80–130 mg/dL; ±4U/day; <i>n</i> = 51), <a>all </a><a>titrated weekly. </a>Percentage time in range (TIR; 70–180 mg/dL) during weeks 15&16 was measured using continuous glucose monitoring.</p> <p><b>RESULTS</b></p> <p>TIR improved from baseline (means: A, 57.0%; B, 55.2%; C, 51.0%; IGlar U100, 55.3%) to weeks 15&16 (estimated mean: A, 76.6%; B, 83.0%; C, 80.9%; IGlar U100, 75.9%). TIR was greater for titration B than for IGlar U100 (estimated treatment difference: 7.08%-points; 95% CI, 2.12%–12.04%; <i>P </i>= 0.005). No unexpected safety signals were observed. Level 2 hypoglycemia (<54 mg/dL) was low in all groups (0.05, 0.15, 0.38, 0.00 events per patient/year for icodec titrations A, B, C, IGlar U100, respectively), with no episodes of severe hypoglycemia.</p> <p><b>CONCLUSION</b></p> <p>Once-weekly icodec was efficacious and well tolerated across all three titration algorithms investigated. <a></a><a></a><a>Icodec titration A (80–130 mg/dL; ±21U/week) displayed the best balance between glycemic control and risk of hypoglycemia.</a> </p>

Background DUAL I China, one of the DUAL trials, assessed efficacy/safety of insulin degludec/liraglutide (IDegLira) in Chinese adults with type 2 diabetes (T2D) not controlled by oral antidiabetic drugs (OADs). Methods This phase 3a, treat‐to‐target multicenter trial randomized participants (glycated hemoglobin [HbA1c] 53.0‐85.8 mmol/mol; previous metformin ± another OAD) 2:1:1 to IDegLira (n = 361), degludec (n = 179), or liraglutide (n = 180). Primary endpoint was change in HbA1c after 26 weeks. Secondary endpoints included: HbA1c < 53.0 mmol/mol attainment, weight change, treatment‐emergent hypoglycemia, end‐of‐treatment insulin dose, and safety. Results At 26 weeks, HbA1c had decreased by a mean 18.12 mmoL/moL (IDegLira), 12.37 mmoL/moL (degludec) (estimated treatment difference [ETD] −6.50 mmoL/moL; 95% confidence interval [CI] −7.96, −5.04; P < .0001), and 11.33 mmoL/moL (liraglutide) (ETD −6.87 mmoL/moL; 95% CI −8.33, −5.41; P < 0.0001), indicating noninferiority for IDegLira vs degludec and superiority vs liraglutide. HbA1c < 53.0 mmoL/moL attainment was 77.0% (IDegLira), 46.4% (degludec), and 48.3% (liraglutide). Mean weight change with IDegLira (0.1 kg) was superior to degludec (1.2 kg) (ETD −1.08 kg; 96% CI −1.55, −0.62; P < 0.0001). Severe or confirmed hypoglycemic event rates were 0.24 (IDegLira) and 0.17 (degludec) episodes/participant‐year (estimated rate ratio 1.46; 95% CI 0.71, 3.02; P = .3008, not significant). At the end of treatment, the IDegLira insulin dose was lower (24.5 U/d) vs degludec (30.3 U/d) (ETD −5.49 U; 95% CI −7.77, −3.21; P < 0.0001). No unexpected safety issues occurred. Conclusions IDegLira is efficacious and well tolerated in Chinese adults with T2D not controlled by OADs.