Basal insulin glargine using a basal-bolus regimen in a common clinical practice: observational, non-interventional, multicenter, national project LINDA (Lantus in daily practice - safety and efficacy in basal bolus regimen)
Abstract
Objective: To evaluate the safety and efficacy of basal insulin glargine using a basal-bolus regimen in a common clinical practice setting in the Czech Republic. Patients and methods: The LINDA project was a non-interventional, multicenter (n = 255), national, observational project.
A total of 4,998 patients with Type 1 and 2 diabetes mellitus (T1DM, T2DM) with predominantly insulin therapy (99,7 %), after switch on insulin glargine at basal-bolus regimen, were enrolled in this project. The patients were followed up for 6 months after initiation of the therapy with insulin glargine.
The primary objective of the project was to investigate the incidence of severe hypoglycemic episodes during the treatment with basal insulin analogue glargine (Lantus?) in a common clinical practice setting. The se-condary endpoints were changes in glycosylated hemoglobin (HbA1c) levels, fasting plasma glucose (FPG), body weight, insulin dose, change of number of hypoglycemic episodes in comparison the previous therapy and the frequency of adverse effects.