Dataset from 52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy

Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin
regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin
regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin
glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of
blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting
plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic
events, adverse events, change of late diabetes complications, weight, body-mass-index,
course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria,
standard lab and quality of life/treatment satisfaction.