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identical amino acid sequence

to Lantus®

(insulin glargine injection)1,2

Amino acid sequences Amino acid sequences

BASAGLAR was approved based, in part, on results of an extensive clinical development program.1

Basaglar®

(insulin glargine injection) 100 units/mL

Pharmacokinetic

(PK) PROFILE

BASAGLAR and Lantus (US-approved)

PK properties over a 24-hour period3

BASAGLAR PK profile vs Lantus*

*Serum insulin concentration.

Approved in the US.

A phase 1 randomized, double-blind, single-dose, 2-treatment, 4-period, crossover, replicate treatment, euglycemic clamp study with 91 healthy subjects evaluated the PK and pharmacodynamic (PD) profiles for BASAGLAR and Lantus (US-approved) given subcutaneously as single, 0.5 unit/kg doses.3

PK results: Based on statistical comparisons of area under the plasma concentration–time curve from 0 to 24 hours (AUC0-24) and maximum plasma concentration (Cmax) of BASAGLAR and Lantus (US-approved), the ratios of least squares (LS) geometric means were 0.90 and 0.92 for AUC0-24 and Cmax, respectively, with 90% confidence intervals (CIs) for the ratios contained within the prespecified interval of 0.80 to 1.25.3

Basaglar®

(insulin glargine injection) 100 units/mL

PHARMACODYNAMIC

(PD) PROFILE

BASAGLAR and Lantus (US-approved)

PD properties over a 24-hour period3

BASAGLAR PD profile vs Lantus*

*Glucose infusion rate.

Approved in the US.

A phase 1 randomized, double-blind, single-dose, 2-treatment, 4-period, crossover, replicate treatment, euglycemic clamp study with 91 healthy subjects evaluated the PK and PD profiles for BASAGLAR and Lantus (US-approved) given subcutaneously as single, 0.5 unit/kg doses.3

PD results: Based on statistical comparisons of total glucose infusion over the clamp duration (Gtot) and maximum glucose infusion rate (Rmax) of BASAGLAR and Lantus (US-approved), the ratios of LS geometric means were 0.91 and 0.93, respectively, for Gtot and Rmax, with 90% CIs for the ratios contained within the prespecified interval of 0.80 to 1.25.3

The pharmacodynamic profile of BASAGLAR demonstrated sustained glucose-lowering activity over 24 hours with no pronounced peak1,3