With the same amino acid sequence as Lantus® (insulin glargine injection),1,2 you'll soon have another choice in insulin glargine.
*Specific timing on product availability may vary by location.
BASAGLAR has been approved based, in part, on the results from an extensive clinical development program.
BASAGLAR demonstrated noninferiority to US- or non-US-approved Lantus as measured by A1C reductions from baseline
Change in A1C from baseline at 24 weeks in adult patients with type 2 diabetes
*Three patients randomized to BASAGLAR did not receive study drug and were not included in the full analysis set. Observed A1C data at 24 weeks were available from 331 (88%) and 329 (87%) patients randomized to the BASAGLAR and US- or non-US-approved Lantus groups, respectively.
OAMs=oral antidiabetic medications; CI=confidence interval.
A comparable percentage of adult patients with type 2 diabetes achieved A1C <7% at 24 weeks*
*Secondary endpoint.
†Three patients randomized to BASAGLAR did not receive study drug and were not included in the full analysis set. Observed A1C data at 24 weeks were available from 331 (88%) and 329 (87%) patients randomized to the BASAGLAR and US- or non-US-approved Lantus groups, respectively.
OAMs=oral antidiabetic medications.
Trial design: 24-week, phase 3, randomized, double-blind trial of 756 adult patients with type 2 diabetes who were either insulin-naive and failed to achieve adequate glycemic control on at least 2 oral antidiabetic medications (OAMs), or were already on US- or non-US-approved Lantus along with 2 or more OAMs with adequate or inadequate glycemic control. The primary endpoint was noninferiority of BASAGLAR to US- or non-US-approved Lantus as measured by change in A1C from baseline at 24 weeks.1,3
The starting dose for all insulin-naive patients was 10 units/day, while patients entering the study on US- or non-US-approved Lantus were randomized to either BASAGLAR or US- or non-US-approved Lantus at a dose equivalent to their prestudy US- or non-US-approved Lantus dose; BASAGLAR and US- or non-US-approved Lantus titration was patient-driven based on self-measured fasting plasma glucose with a target of <100 mg/dL.3
BASAGLAR Adverse Events
1% of adult patients with type 2 diabetes taking BASAGLAR (n=2) experienced severe symptomatic hypoglycemia at 24 weeks1,4
Type 2 diabetes: adverse reactions occurring in ≥5% of adult patients (n=376) treated with BASAGLAR + OAMs over 24 weeks1
*Infections other than nasopharyngitis or upper respiratory tract infection.
OAMs=oral antidiabetic medications.
Hypoglycemia was the most commonly observed adverse reaction in patients using insulin, including BASAGLAR. Hypoglycemia was defined as blood glucose ≤3.9 mmol/L (≤70 mg/dL) or a sign or symptom associated with hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia that required assistance of another person, and was associated with either blood glucose levels below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.1,3
BASAGLAR demonstrated noninferiority to US- or non-US-approved Lantus as measured by A1C reductions from baseline
Change in A1C from baseline at 24 weeks in adult patients with type 1 diabetes
*One patient randomized to the BASAGLAR group was not included in the full analysis set. Observed A1C data at 24 weeks were available from 256 (96%) and 258 (97%) patients randomized to the BASAGLAR and US- or non-US-approved Lantus groups, respectively.
CI=confidence interval.
A comparable percentage of adult patients with type 1 diabetes achieved A1C <7% at 24 weeks*
*Secondary endpoint.
†One patient randomized to the BASAGLAR group was not included in the full analysis set. Observed A1C data at 24 weeks were available from 256 (96%) and 258 (97%) patients randomized to the BASAGLAR and US- or non-US-approved Lantus groups, respectively.
Trial design: 52-week, phase 3, randomized, open-label study of 535 adult patients with type 1 diabetes who were also treated with insulin lispro. The primary endpoint was noninferiority of BASAGLAR to US- or non-US-approved Lantus as measured by change in A1C from baseline at 24 weeks.1,5
Patients started on the same dose of BASAGLAR or US- or non-US-approved Lantus and at the same time of day as their prestudy basal insulin; mealtime insulin was replaced with insulin lispro at doses equivalent to prestudy mealtime insulin; titration was investigator-driven based on self-measured fasting plasma glucose to achieve glycemic targets (A1C <7%, fasting plasma-equivalent glucose ≤108 mg/dL, and other preprandial capillary blood glucoses [70 to 130 mg/dL]).5
BASAGLAR Adverse Events
4% of adult patients with type 1 diabetes taking BASAGLAR (n=10) experienced severe symptomatic hypoglycemia at 52 weeks1,6
Type 1 diabetes: adverse reactions occurring in ≥5% of adult patients (n=268) treated with BASAGLAR + insulin lispro over 52 weeks1,7
*Infections other than nasopharyngitis or upper respiratory tract infection.
Hypoglycemia was the most commonly observed adverse reaction in patients using insulin, including BASAGLAR. Hypoglycemia was defined as blood glucose ≤3.9 mmol/L (≤70 mg/dL) or a sign or symptom associated with hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia that required assistance of another person, and was associated with either blood glucose levels below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.1,5
For more information, please see full Prescribing Information, including Patient Information, and Instructions for Use.
The difference has to do with how insulin glargine was originally approved in the US, and is now categorized.
Approval pathways for biologics
How a follow-on biologic gets approved in the US
New biologic files for approval in 1 of 2 ways*
BASAGLAR is considered a biosimilar in the European Union (EU) because it was approved under their biosimilar regulatory pathway.
The US Food and Drug Administration (FDA) approval of BASAGLAR follows regulatory approval in several regions and countries around the world, including the European Union, the European Economic Area, Canada, Colombia, Japan, and Australia.
BASAGLAR has been officially approved by the US Food and Drug Administration (FDA) for use and will be available in the US starting on December 15, 2016. Specific timing on product availability may vary by location.
BASAGLAR will be available in a 3 mL prefilled KwikPen®
BASAGLAR KwikPen must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood-borne pathogens.1
Not actual size
BASAGLAR — the pharmacodynamic (PD) profile demonstrated sustained glucose-lowering activity over 24 hours with no pronounced peak1,9
Study design: Phase 1 randomized, double-blind, single-dose, 2-treatment, 4-period, crossover, replicate-treatment, euglycemic clamp study with 91 healthy subjects.9
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