BASAGLAR® (insulin glargine injection): HbA1c Results in Patients With T2DM

Clinical Study - Type 2 Diabetes Mellitus

Adult patients with T2DM participated in a double-blind, active-controlled study to evaluate the glucose lowering effect of once-daily Basaglar plus OAMs compared with that of another IG-100 product or a non-US-approved IG-100 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 IG-100 product or a non-US-approved IG-100 product along with at least 2 OAMs with adequate or inadequate glycemic control (~40%).¹

Results

Characteristics of the 759 randomized patients included

• 78% white

• 50% male

• a mean age of approximately 59 years

• a mean BMI of approximately 32 kg/m², and

• 68% with a GFR >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

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 T2DM in a Phase 3 Clinical Study of Basaglar ).¹

Table 1. Efficacy Results in Adult Patients With T2DM in a Phase 3 Clinical Study of Basaglar¹

HbA1c, %	Basaglar + OAMs (n=376)a	Comparator IG-100 Productsb + OAMs (n=380)
Baseline, mean	8.35	8.31
Change from baseline, adjusted meanc	-1.3	-1.3
Difference from comparator, adjusted meanc (95% CI)	0.05 (-0.07, 0.17)
Percentage of patients achieving HbA1c < 7%c	48.8	52.5

Abbreviations: Basaglar = Basaglar® (insulin glargine injection) 100 units/mL; HbA1c = glycated hemoglobin; IG-100 = insulin glargine 100 units/mL; OAM = oral antihyperglycemic medication; T2DM = type 2 diabetes mellitus.

^a A total of 3 patients randomized to the Basaglar treatment group did not receive study drug and were 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 331 (88%) patients in the Basaglar treatment group and 329 (87%) patients in the comparator IG-100 treatment group.

Enclosed Prescribing Information

BASAGLAR® (insulin glargine injection), for subcutaneous 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

GFR = glomerular filtration rate

HbA1c = glycated hemoglobin

IG-100 = insulin glargine 100 units/mL

OAM = oral antihyperglycemic medication

T2DM = type 2 diabetes mellitus