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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 2 diabetes patients on Basaglar® (insulin glargine)?
In patients with type 2 diabetes, treatment with Basaglar provided a mean change in HbA1c of ‑1.3 at 24 weeks that was noninferior to that achieved with comparator insulin glargine 100 units/mL products.
Basaglar Clinical Study: Type 2 Diabetes
Adult patients with type 2 diabetes participated in a double-blind, active-controlled study to evaluate the glucose lowering effect of once-daily Basaglar® (insulin glargine) 100 units/mL plus oral antihyperglycemic medications (OAMs) compared with that of another insulin glargine 100 units/mL product or a non‑US‑approved insulin glargine 100 units/mL product administered once daily along with OAMs. Patients were
- insulin naïve (~60%) and had failed to achieve adequate glycemic control on at least 2 OAMs, or
- already on another insulin glargine 100 units/mL product or a non‑US‑approved insulin glargine 100 units/mL product along with at least 2 OAMs with adequate or inadequate glycemic control (~40%).1
Patient Characteristics
Characteristics of the 759 randomized patients included
- 78% White
- 50% male
- a mean age of approximately 59 years
- a mean body mass index of approximately 32 kg/m2, and
- 68% with a glomerular filtration rate >90 mL/min/1.73m2.1
A total of 3 patients randomized to Basaglar did not receive study drug and were not included in efficacy analysis.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 2 Diabetes in a Phase 3 Clinical Study of Basaglar).1
HbA1c, % |
Basaglar + OAMs |
Comparator Insulin Glargine 100 Units/mL Productsb + OAMs |
Baseline, mean |
8.35 |
8.31 |
Change from baseline, adjusted meanc |
-1.3 |
-1.3 |
Difference from comparator, adjusted mean (95% CI)c |
0.05 (-0.07 to 0.17) |
|
Abbreviations: Basaglar = Basaglar® (insulin glargine) 100 units/mL; HbA1c = glycated hemoglobin; OAMs = oral antihyperglycemic medications.
aA total of 3 patients randomized to the Basaglar treatment group did not receive study drug and were 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 331 patients (88%) in the Basaglar treatment group and 329 patients (87%) 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: October 25, 2021