drugset / Trial / NCT01127269

Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

NCT01127269 ↗

Phase 4 Completed 178 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months Secondary Objectives: * Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months * Insulin glargine dose at 3 and 6 months * Hypoglycemic episodes (all types)

Timeline

Start
2010-05
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic 100 unknown Subcutaneous