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Key publication slides Heise T, et al. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes, Obesity and Metabolism. 2015;17:682-8. Key publication slides No FXCX

Background and Objectives Fast-acting insulin analogues (e.g. insulin lispro, IAsp) provide a more physiological insulin profile than regular human insulin, and represent an important advance in the treatment of diabetes1,2 However, current fast-acting insulin analogues are still absorbed too slowly and do not mimic physiological insulin activity seen in healthy individuals3,4 Ultra-fast-acting IAsp is a new formulation of IAsp designed to accelerate absorption, thereby improving postprandial glycaemic control5 The aim of this study was to compare the PK/PD properties of ultra-fast-acting IAsp and IAsp in patients with T1D5 1. Brunner GA, et al. Diabet Med. 2000;17:371-5. 2. Heinemann L, et al. Diabet Med. 1996;13:625-9. 3. Heinemann L, Muchmore DB. J Diabetes Sci Technol. 2012;6:728-42. 4. Home PD. Diabetes Obes Metab. 2015;17:1011-20. 5. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8. IAsp, insulin aspart; PD, pharmacodynamic; PK, pharmacokinetic; T1D, type 1 diabetes.

Study Design Randomized, double-blind, single-dose, crossover, phase 1 trial (N = 52a) Patients with T1D Age 18–64 years HbA1c ≤ 8.5% BMI 18–28 kg/m2 Treated with MDI or CSII for ≥ 12 months Ultra-fast-acting IAsp single dose (0.2 U/kg) IAsp single dose(0.2 U/kg) IAsp single dose (0.2 U/kg) Ultra-fast-acting IAsp single dose (0.2 U/kg) a 1 patient withdrew consent after 1 dose. BMI, body mass index; CSII, continuous subcutaneous insulin infusion; HbA1c, glycated haemoglobin A1c; MDI, multiple daily injections; U, units. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.

Ultra-fast-acting IAsp (n = 51) Results: Early Onset of Insulin Exposure With Ultra-Fast-Acting IAsp vs IAsp Onset of insulin exposure, minutes Ultra-fast-acting IAsp (n = 51) IAsp (n = 51) Treatment ratio [95% CI] Onset of appearance 4.9 11.2 0.43 [0.36; 0.51] t50%Cmax 20.7 31.6 0.65 [0.59; 0.72] Faster onset of appearance with ultra-fast-acting IAsp Earlier t50%Cmax with ultra-fast-acting IAsp CI, confidence interval; t50%Cmax, time to reach 50% maximum concentration. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.

Results: Greater Early Exposure With Ultra-Fast-Acting IAsp vs IAsp 1.3-fold increase in insulin AUC [95% CI 1.15; 1.43] 2.1-fold increase in insulin AUC [95% CI 1.76; 2.38] 4.5-fold increase in insulin AUC [95% CI 3.62; 5.66] AUC0–15 minutes AUC0–30 minutes AUC0–1 hour AUC0–1.5 hours AUC, area under the curve. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.

Ultra-fast-acting IAsp (n = 51) Results: Early Onset of Glucose-Lowering Effect With Ultra-Fast-Acting IAsp vs IAsp Onset of glucose-lowering effect, minutes Ultra-fast-acting IAsp (n = 51) IAsp (n = 51) Treatment ratio [95% CI] t50%GIRmax 38.3 46.1 0.83 [0.73; 0.94] tGIRmax 124.3 135.2 0.92 [0.84; 1.01] Faster t50%GIRmax with faster-acting Iasp Similar tGIRmax t50%GIRmax, time to reach 50% maximum glucose infusion rate; tGIRmax, time to reach maximum glucose infusion rate. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.

Results: Greater Early Glucose-Lowering Effect With Ultra-Fast-Acting IAsp vs IAsp 1.2-fold increase in insulin AUC [95% CI 1.05; 1.30] 1.3-fold increase in insulin AUC [95% CI 1.18; 1.46] 1.5-fold increase in insulin AUC [95% CI 1.13; 2.02] AUCGIR, 0–30 minutes AUCGIR, 0–1 hour AUCGIR, 0–1.5 hour AUCGIR, 0–2 hours GIR, glucose infusion rate. Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.

Conclusions The new ultra-fast-acting formulation of IAsp has a more favourable PK/PD profile than IAsp In the first 30 minutes following exposure, ultra-fast-acting IAsp is characterized by a: 57% earlier onset of appearance (4.9 minutes for ultra-fast-acting vs 11.2 minutes for IAsp) 2.1-fold increase in insulin exposure 1.5-fold increase in glucose-lowering effect Total insulin exposure and glucose-lowering effects were similar for ultra-fast-acting IAsp and IAsp These data suggest that ultra-fast-acting IAsp provides a more physiological insulin profile that may improve postprandial glycaemic control in patients with diabetes Heise T, et al. Diabetes Obes Metab. 2015;17:682-8.