NCT05002933

A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.

Detailed description

Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine 300 U/ml	Solution for injection Subcutaneous injection

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2021-08-12
• Last updated: 2025-09-22

Locations

1 site across 1 country: China