BASAGLAR® (insulin glargine injection): Primary Endpoint Results in Clinical Studies

Clinical Studies - Type 1 and Type 2 Diabetes Mellitus

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

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

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 or T2DM in Phase 3 Clinical Studies of Basaglar ).¹

Table 1. Efficacy Results in Adult Patients With T1DM or T2DM in Phase 3 Clinical Studies of Basaglar¹

	Basaglar + Insulin Lispro  (n=268)a	Comparator IG-100 Productsb + Insulin Lispro (n=267)	Basaglar + OAMs  (n=376)c	Comparator IG-100 Productsb + OAMs  (n=380)
Patient population	T1DM		T2DM
HbA1c, %
Baseline, mean	7.75	7.79	8.35	8.31
Change from baseline, adjusted meand	-0.35	-0.46	-1.3	-1.3
Difference from comparator, adjusted meand (95% CI)	0.11 (-0.002, 0.219)		0.05 (-0.07, 0.17)

Abbreviations: Basaglar = Basaglar® (insulin glargine injection) 100 units/mL; HbA1c = glycated hemoglobin; IG-100 = insulin glargine 100 units/mL; OAM = oral antihyperglycemic medication; T1DM = type 1 diabetes mellitus; T2DM = type 2 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 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.

^d 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 in patients with T1DM and from 331 (88%) patients in the Basaglar treatment group and 329 (87%) patients in the comparator IG-100 treatment group in patients with T2DM.

Enclosed Prescribing Information

BASAGLAR® (insulin glargine injection), for subcutaneous use, Lilly

HUMALOG® (insulin lispro injection), for subcutaneous or intravenous use, Lilly

Reference

1. Basaglar [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

Glossary

Basaglar = Basaglar® (insulin glargine injection) 100 units/mL

HbA1c = glycated hemoglobin

IG-100 = insulin glargine 100 units/mL

OAM = oral antihyperglycemic medication

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus