l  GLITTER 1 Phase III clinical study shows that Basalin^?? and Lantus^?? demonstrated similar immunogenicity, efficacy, and safety in patients with type 1 diabetes.

l  GLITTER 2 Phase III clinical study shows that Basalin^?? and Lantus^?? demonstrated similar immunogenicity, efficacy, and safety in patients with type 2 diabetes.

In October 2023, Gan & Lee Pharmaceuticals presented data from two overseas Phase III clinical studies of Basalin^?? at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting. The results of the studies showed that Basalin^?? is bioequivalent to Lantus^?? in terms of immunogenicity, efficacy, and safety. The study adds further strong evidence to support the efficacy and safety of Basalin^?? for the treatment of diabetes.

The results of the GLITTER 1 and GLITTER 2 Phase III clinical trials were disclosed in a short oral discussion on October 5 at EASD.

GLITTER 1 is an open-label, randomized, multicenter, Phase III study enrolled 576 subjects with T1DM (HbA1c ≤11.0%) who had been on an approved basal and bolus insulin regimen for at least 6 months prior to screening. Eligible subjects were randomized 1:1 to receive either GL Glargine Injection (N = 287) or EU Lantus (N = 289) once daily for 26 weeks, with insulin dose optimized according to pre-treatment fasting glucose. Efficacy and safety were evaluated by the change in glycosylated hemoglobin (HbA1c) and the incidence and severity of all treatment-emergent adverse events (TEAEs) at 26 weeks. Immunogenicity was assessed by the proportion of patients developing treatment-induced anti-insulin antibodies (AIA) between treatment groups, defined as the development of a new confirmed positive AIA or a significant (at least fourfold) increase in titer from baseline to week 26.

The key efficacy endpoint of GL Glargine Injection was shown to be bioequivalent to EU Lantus, as the least-squares mean difference in change from baseline in HbA1c was -0.08%, with the 90% CI of the treatment difference (-0.23, 0.06) within the predefined equivalence limits (-0.4%, 0.4%). In addition, the safety profile of GL glargine injection was also comparable to EU Lantus, with similar rates of TEAEs reported in both groups (90.2% vs. 92.4%).

 The study also demonstrated immunogenicity BE between GL Glargine Injection and the reference insulin, as the percentage of subjects testing positive for treatment-induced AIA was similar between the two groups (25.8% vs. 25.3%) and the 90% confidence interval (CI) (-5.4, 6.5) of the difference in proportions was well contained within the predefined similarity margins of -11.3 to 11.3.

GLITTER 2 is a Phase III, open-label, randomized, multicenter, 26-week study enrolled 567 patients with T2DM (HbA1c ≤11.0%). Participants were randomized 1:1 to receive once-daily doses of GL Glargine Injection (N = 284) or EU Lantus (N = 283), individually adjusted for metabolic status. During the four weeks following randomization, these subjects had their insulin and other antidiabetic medication (OAM) doses optimized based on fasting glucose results. Efficacy and safety were assessed by the change in glycated hemoglobin (HbA1c) and the incidence and severity of all treatment-emergent adverse events (TEAEs) at 26 weeks. Immunogenicity was also assessed by the incidence of treatment-induced anti-insulin antibodies (AIA), defined as the development of a new confirmed positive AIA or at least a fourfold increase in titer from baseline to week 26.

Key secondary efficacy endpoints met BE criteria, with the least-squares mean the difference between treatment groups in the change from baseline in HbA1c was 0.06% and the 90% CI of the treatment difference (-0.13, 0.26) falling within the predefined equivalence ranges (-0.4%, 0.4%). In addition, the percentage of subjects with TEAEs in the GL glargine injection group was similar to that in the EU Lantus group. 

Immunogenicity bioequivalence was also demonstrated as the proportions of subjects testing positive for treatment-induced AIA through week 26 were similar between the GL Glargine Injection (19.2%) and EU Lantus (21.3%) treatment groups, and the 90% confidence intervals (CIs) of the difference in proportions were well within the predefined similarity ranges of -10.7 to 10.7.

GLITTER Study

The first ever global Phase III clinical trial series conducted by a Chinese pharma for a domestically manufactured biosimilar insulin. It was designed to demonstrate that Gan & Lee Pharmaceuticals' insulin glargine Basalin^?? has comparable efficacy, safety, and immunogenicity to the originator reference drug Lantus^?? in patients with type 1 diabetes (GLITTER1 study) and type 2 diabetes (GLITTER2 study). Both two GLITTER studies were randomized, open-label, parallel-controlled trials designed to enroll 576 patients with type 1 diabetes and 567 patients with type 2 diabetes, respectively, to compare the changes in efficacy, safety, and immunogenicity between Basalin^?? and Lantus^?? in patients after 26 weeks of continuous administration.

The results of the GLITTER studies were also presented at EASD 2023 in the ePoster session. To view the ePoster, please visit the Gan & Lee - Medical Product Information website at https://www.ganleediabetes.com.

References:

1. W. Chen, et al. Efficacy, safety, and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 1 diabetes. Diabetologia 66 (Suppl 1), 1–536 (2023). https://doi.org/10.1007/s00125-023-05969-6  

2. E. Christofides, et al. Efficacy, safety, and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 2 diabetes. Diabetologia 66 (Suppl 1), 1–536 (2023). https://doi.org/10.1007/s00125-023-05969-6

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^?), fast-acting lispro injection (Prandilin^?), fast-acting aspart injection (Rapilin^?), mixed protamine zinc lispro injection (25R) (Prandilin^?25), aspart 30 injection (Rapilin^?30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^?30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^?).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.