Basaglar ® (insulin glargine injection)

100 units/mL

The below information is provided in response to your request and may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above.

BASAGLAR® (insulin glargine injection): HbA1c Results in Patients With T1DM

In patients with T1DM, at week 24, treatment with Basaglar provided a mean reduction in HbA1c that was noninferior to that achieved with comparator IG-100 products.

Clinical Study - Type 1 Diabetes Mellitus

Adult patients with inadequately controlled T1DM participated in a 24-week, open-label, active-controlled study with a 28-week extension to evaluate the glucose lowering effect of once-daily Basaglar compared with that of once-daily administration of another IG-100 product or a non-US-approved IG-100 product, both in combination with mealtime insulin lispro.1

Results

Characteristics of the 535 randomized patients included

  • 57.9% male

  • 74.5% Caucasian

  • 2.1% black or African American

  • 4.3% American Indian or Alaskan native

  • 3.9% Hispanic

  • a mean age of 41.2 years

  • a mean BMI of approximately 25.54 kg/m2

  • a mean duration of DM of 16.39 years, and 

  • 73.5% with a GFR >90 mL/min/1.73m2.1

At week 24, treatment with Basaglar provided a mean reduction in HbA1c that was noninferior to that achieved with comparator IG-100 products (Table 1. Efficacy Results in Adult Patients With T1DM in a Phase 3 Clinical Study of Basaglar ).1

Table 1. Efficacy Results in Adult Patients With T1DM in a Phase 3 Clinical Study of Basaglar1

HbA1c, % 

Basaglar + Insulin Lispro
(n=268)a

Comparator IG-100 Productsb + Insulin Lispro
(n=267)

Baseline, mean

7.75

7.79

Change from baseline, adjusted meanc

-0.35

-0.46

Difference from comparator, adjusted meanc (95% CI)

0.11 (-0.002, 0.219)

Percentage of patients achieving
HbA1c < 7%c

34.5

32.2

Abbreviations: Basaglar = Basaglar® (insulin glargine injection) 100 units/mL; HbA1c = glycated hemoglobin; IG-100 = insulin glargine 100 units/mL; T1DM = type 1 diabetes mellitus.

a Includes 1 patient randomized to the Basaglar treatment group who was not included in the full analysis set.

b Another IG-100 product and a non-US-approved IG-100 product.

c Results were calculated based on the number of patients in the full analysis set using their last observed postbaseline value of HbA1c. Observed HbA1c data at 24 weeks were available from 256 (95.5%) patients in the Basaglar treatment group and 258 (96.6%) patients in the comparator IG-100 treatment group.

Enclosed Prescribing Information

BASAGLAR® (insulin glargine injection), for subcutaneous use, Lilly

HUMALOG® (insulin lispro injection), for subcutaneous or intravenous use, Lilly

Reference

1. Basaglar [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

Glossary

Basaglar = Basaglar® (insulin glargine injection) 100 units/mL

BMI = body mass index

DM = diabetes mellitus

GFR = glomerular filtration rate

HbA1c = glycated hemoglobin

IG-100 = insulin glargine 100 units/mL

T1DM = type 1 diabetes mellitus

Date of Last Review: January 04, 2019

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