Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL

Summary

Primary Objective: To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients. Secondary Objectives: * To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events. * To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.

Timeline

Start

2018-01-22

Primary completion

2019-02-04

Completion

2019-02-04

Outcome

Missed primary endpoint

paper After switching from BID to OD insulin regimen, no significant change in HbA1c was observed from baseline to Week 24 (p = 0.873). PMID 38982528 ↗

Publications

• Dualib PM, Dib SA, Augusto GA, Truzzi AC, de Paula MA, Rea RR. Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes. Diabetol Metab Syndr. 2024 Jul 9;16(1):152. doi: 10.1186/s13098-024-01385-x.

Drugs

Indications