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ADMELOG is highly similar to Humalog® in structure and pharmacology

ADMELOG is an insulin lispro with an amino acid sequence identical to Humalog1,2

ADMELOG demonstrated a pharmacokinetic (PK) profile similar to Humalog

ADMELOG was similar to Humalog in its fast absorption with a rapid onset of action1,3

MEAN PLASMA INSULIN CONCENTRATION VS TIME

PK RESULTS: The median time to maximum plasma insulin concentration was ~50 minutes (0.83 hours) after injection. The mean observed area under the plasma insulin concentration time curve from time zero to infinity and peak plasma insulin concentration were 12,800 pg/hr/mL and 5070 pg/mL, respectively.1

STUDY DESIGN: This study was a single-center, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycemic clamp study. Adult patients (N=30) with type 1 diabetes were randomized to receive 0.3 U/kg dose of either ADMELOG or Comparator (Humalog, or a non–US-approved insulin lispro, 100 Units/mL) under fasted conditions. The pharmacokinetic and pharmacodynamic profiles were evaluated over 12 hours.1,3

The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables.

ADMELOG showed a pharmacodynamic (PD) profile similar to Humalog

ADMELOG was similar to Humalog in having a short duration of action1,3

GLUCOSE INFUSION RATE VS TIME

PD RESULTS: The mean (SD) time to maximum effect of ADMELOG was approximately 2.07 (0.78) hours. The mean (SD) area under the glucose infusion rate curves and mean (SD) maximum glucose infusion rate were 1953.5 (547.3) mg/kg and 9.97 (2.37) mg/min/kg, respectively.1

STUDY DESIGN: This study was a single-center, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycemic clamp study. Adult patients (N=30) with type 1 diabetes were randomized to receive 0.3 U/kg dose of either ADMELOG or Comparator (Humalog, or a non–US-approved insulin lispro, 100 Units/mL) under fasted conditions. The PK and PD profiles were evaluated over 12 hours.1,3

The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables.

GIR=glucose infusion rate; SD=standard deviation.

References:

1. ADMELOG Prescribing Information.

2. Humalog Prescribing Information.

3. Kapitza C, Nowotny I, Lehmann A, et al. Diabetes Obes Metab. 2017;19(5):622-627.