Introduction
The clinical benefits of insulin glargine 300 U/ml (Gla-300) have been confirmed in randomized clinical trials (EDITION and BRIGHT) and real-world studies (ATOS, Toujeo-1, and ORION) in different regions of the world. However, safety data for the Indian population are lacking. The current post-marketing surveillance study evaluated the safety and efficacy of Gla-300 in people with type 2 diabetes (T2D) from India.
Methods
SAFEGUARD was a multicenter, phase 4, single-arm, open-label, 24-week study conducted at 15 centers across India between August 10, 2021 and December 26, 2022. The study included insulin-naïve participants (aged ≥ 18 years) with T2D uncontrolled (HbA1c ≥ 7.5% and ≤ 10%) on oral anti-hyperglycemic drugs. The primary endpoint was the percentage of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and hypoglycemic episodes.
Results
Of the 220 participants included, 218 (36.8% female) were eligible for efficacy analysis. The mean ± standard deviation age was 54.0 ± 9.6 years, the baseline HbA1c was 8.8 ± 0.9%, and the duration of T2D was 9.3 ± 7.0 years. Among the 220 participants who took at least one dose of Gla-300, 24.5% (n = 54) reported 64 TEAEs, which included one (0.5%) SAE. The most reported event was infections (10.9%). In total, 29.5% of participants (n = 65) reported a level 1 hypoglycemic event, and 27.7% of participants (n = 18) reported the main symptom of sweating. Glycemic control improved with reductions in mean HbA1c levels (− 1.14 ± 1.2%), fasting plasma glucose (− 37.0 ± 59.3 mg/dl), and fasting self-monitored blood glucose (− 52.0 ± 44.1 mg/dl) from baseline to week 24.
Conclusions
Gla-300 was well tolerated with improved glycemic control and a low hypoglycemia risk in insulin-naïve people with T2D living in India.
Trial Registration
Clinical Trials Registry—India (CTRI number): CTRI/2021/07/035244. WHO identifier number: U1111-1255-5143. NCT number: NCT04980027.
