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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
Characteristics of the 535 randomized patients included
2.1% black or African American
4.3% American Indian or Alaskan native
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
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 = 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