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Basaglar ® (insulin glargine) injection
100 units/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the change in HbA1c in type 1 diabetes patients on Basaglar® (insulin glargine)?
In patients with type 1 diabetes, treatment with Basaglar provided a mean change in HbA1c of ‑0.35 at 24 weeks that was noninferior to that achieved with comparator insulin glargine 100 units/mL products.
Basaglar Clinical Study: Type 1 Diabetes
Adult patients with inadequately controlled type 1 diabetes 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® (insulin glargine) 100 units/mL compared with that of once-daily administration of another insulin glargine 100 units/mL product or a non-US-approved insulin glargine 100 units/mL product, both in combination with mealtime insulin lispro.1
Patient Characteristics
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 body mass index of approximately 25.54 kg/m2
- a mean duration of diabetes of 16.39 years, and
- 73.5% with a glomerular filtration rate >90 mL/min/1.73m2.1
Change in HbA1c
At week 24, treatment with Basaglar provided a mean reduction in glycated hemoglobin (HbA1c) that was noninferior to that achieved with comparator insulin glargine 100 units/mL products (Efficacy Results in Adult Patients With Type 1 Diabetes in a Phase 3 Clinical Study of Basaglar).1
HbA1c, % |
Basaglar + Insulin Lispro |
Comparator Insulin Glargine 100 Units/mL Productsb + Insulin Lispro |
Baseline, mean |
7.75 |
7.79 |
Change from baseline, adjusted meanc |
-0.35 |
-0.46 |
Difference from comparator, adjusted mean (95% CI)c |
0.11 (-0.002 to 0.219) |
|
Abbreviations: Basaglar = Basaglar® (insulin glargine) 100 units/mL; HbA1c = glycated hemoglobin.
aIncludes 1 patient randomized to the Basaglar treatment group who was not included in the full analysis set.
bAnother insulin glargine 100 units/mL product and a non‑US‑approved insulin glargine 100 units/mL product.
cResults 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 patients (95.5%) in the Basaglar treatment group and 258 patients (96.6%) in the comparator insulin glargine 100 units/mL treatment group.
Enclosed Prescribing Information
Reference
1Basaglar [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
Date of Last Review: April 22, 2024