Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
The primary objective of this study is to obtain efficacy and safety descriptive data on 2
different titration algorithms: the INSIGHT titration algorithm (self-titration of 1
unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as
basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with
or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.
Secondary Objective:
The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin
[A1C], fasting plasma glucose [FPG], 7-point self-measure plasma glucose [SMPG], insulin dose
and weight) and determine patient related outcome and health care professional satisfaction
as it pertains to each titration regimen.