Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naive People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study.

ABSTRACT:

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 o

SUBMITTER: Mohan V 

PROVIDER: S-EPMC12182549 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature