Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Status:
Completed
Trial end date:
2019-02-04
Target enrollment:
Participant gender:
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.