Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Exclusion criteria :
Subjects presenting with any of the following will not be included in the study:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
311 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal