SEMGLEE (insulin glargine-yfgn) injection is a sterile solution for subcutaneous
use. Insulin glargine is a recombinant human long-acting insulin analog. The
primary activity of insulin, including SEMGLEE, is regulation of glucose
metabolism. Insulin and its analogs lower blood glucose by stimulating
peripheral glucose uptake, especially by skeletal muscle and fat, and by
inhibiting hepatic glucose production. Insulin inhibits lipolysis and
proteolysis and enhances protein synthesis. Insulin glargine is metabolized into
2 active metabolites M1 and M2.
The pharmacodynamic profile for SEMGLEE was determined after subcutaneous
administration of a single 0.5 U/kg dose in a euglycemic clamp study conducted
in 116 type 1 diabetes patients.
The median time to maximum effect of SEMGLEE (measured by the peak rate of
glucose infusion) was approximately 11.3 hours. The pharmacodynamic profile of
SEMGLEE following subcutaneous injection demonstrated sustained glucose lowering
activity over 24 hours with no pronounced peak. The arithmetic mean area under
the glucose infusion rate curves (AUC GIR 0-24h) and maximum glucose infusion
rate were 1423 mg/kg and 1.8 mg/kg/min, respectively.
The time course of action of insulin may vary considerably in different
individuals or within the same individual.
After subcutaneous injection of a single 0.5 U/kg dose of SEMGLEE in a euglycemic
clamp study conducted in 116 type 1 diabetes patients, the M1 active metabolite
plasma concentration profile indicated a prolonged absorption and a relatively
constant concentration/time profile over 24 hours.
The median time to maximum M1 plasma concentration was 12 hours after injection. The
mean plasma observed area under the concentration-time curve for M1 from time zero
to 24 hours and peak plasma concentration were 10.5 ng*hr/mL and 0.64 ng/mL,
A metabolism study in humans indicates that insulin glargine is partly metabolized
at the carboxyl terminus of the B chain in the subcutaneous depot to form two active
metabolites with in vitro activity similar to that of human insulin, M1
(21A-Gly-insulin) and M2
(21A-Gly-des30B-Thr-insulin). Unchanged drug and these
degradation products are also present in the circulation.
Age, Race, and Gender
Effect of age, race, and gender on the pharmacokinetics of SEMGLEE has not been
Effect of Body Mass Index (BMI) on the pharmacokinetics of SEMGLEE has not been