Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

Summary

Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)

Timeline

Start

2021-06-07

Primary completion

2022-12-23

Completion

2022-12-23

Publications

• Mohan V, Sethi B, Jain SM, Sahay R, Ramanathan B, Murthy S, Singh KP, Menon S, Gadekar A, Salvi V, Gandhi K. 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. Diabetes Ther. 2025 Jul;16(7):1367-1383. doi: 10.1007/s13300-025-01736-5. Epub 2025 May 8.

Drugs

Indications