drugset / Trial / NCT02227212

Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

NCT02227212

Phase 3 Completed 40 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300. Secondary Objectives: To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients. The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.

Timeline

Start
2014-08
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic Subcutaneous