In patients with uncontrolled type 2 diabetes on IGlar U100 and metformin, IDegLira treatment elicited HbA reductions comparable to basal-bolus, with statistically superior lower hypoglycemia rates and weight loss versus weight gain.

To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basalbolus regimen. RESEARCH DESIGN AND METHODS This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart (n 5 546) or IAsp (n 5 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect. RESULTS Noninferiority for the change from baseline in HbA 1c 16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] 20.04% [95% CI 20.11; 0.03]; 20.39 mmol/mol [21.15; 0.37]; P < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD 20.40 mmol/L [20.66; 20.14]; 27.23 mg/dL [211.92; 22.55]; P 5 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD 20.25 mmol/L [20.42; 20.09]); 24.58 mg/dL [27.59; 21.57]; P 5 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]). CONCLUSIONS In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.

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Aims: To investigate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) in participants with type 2 diabetes (T2D) across different subgroups. Methods: We report on a post hoc analysis of onset 9, a 16-week trial of participants with T2D randomised to faster aspart (n = 546) or IAsp (n = 545). Participants were grouped by baseline HbA1c (\ 7.0%, C 7.0%), meal test bolus insulin dose (B 10 units [U], [ 10 U to B 20 U, [ 20 U), body mass index (\ 30 kg/m 2 , C 30 to \ 35 kg/m 2 , C 35 kg/m 2 ), and age (\ 65 years, C 65 years). Outcomes assessed were change from baseline in HbA1c and in 1-h postprandial glucose (PPG) increment, and severe or blood glucose (BG)-confirmed hypoglycaemia.Results: Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved 1-h PPG control compared with IAsp in several subgroups. Faster aspart had comparable or improved rates of severe or BGconfirmed hypoglycaemia versus IAsp, particularly in participants with good glycaemic control (HbA1c \ 7.0%), the elderly (C 65 years old), and those with insulin resistance ([ 20 U meal test bolus insulin dose). Conclusions: Faster aspart provides effective overall glycaemic control, with improved early PPG control compared with IAsp across a range of patient characteristics. Clinical Trial Registration: NCT03268005.