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.
RESULTS: Severe hypoglycaemia were observed during treatment with
insulin glargine at 0.8 % patients. When comparing the incidence of
hypoglycemia with the previous
therapy, we demonstrated a clinically and statistically significant reduction in their frequencies. The percentage of patients with
hypoglycemic episodes (17.6 %), severe
hypoglycemia (0.8 %) and severe nocturnal
hypoglycemia (0.3 %) over the last month of treatment with
insulin glargine using the basal-bolus regimen was consistently lower compared to the last month of treatment before initiation of this
therapy (42.5 %, 17.6 %, and 13.8 % of the patients, respectively). In patients with T1DM, the incidence of
hypoglycemia decreased from 37.80 ± 15.95 episodes/patient/year to 8.76 ± 4.38 epi-sodes/patient/year (p < 0.001) for all
hypoglycemic episodes; from 5.64 ± 3.27 episodes/patient/year to 0.0396 ± 0.012 episodes/patient/year (p < 0.001) for severe
hypoglycemia; and from 3.84 ± 2.04 episodes/patient/year to 0.0096 ± 0.003 episodes/patient/year (p < 0.001) for severe nocturnal
hypoglycemia. In patients with T2DM, the incidence of
hypoglycemia decreased from 12.48 ± 7.57 episodes/patient/year to 1.68 ± 0.78 episodes/patient/year (p < 0.001) for all
hypoglycemic episodes; from 2.04 ± 0.94 episodes/patient/year to 0.0132 ± 0.005 episodes/patient/year (p < 0.001) for severe
hypoglycemia; and from 1.32 ± 0.77 episodes/patient/year to 0.0048 ± 0.0008 episodes/patient/year (p < 0.001) for severe nocturnal
hypoglycemia. A statistically significant improvement in the metabolic control was demonstrated when using
insulin glargine. The
glycated hemoglobin (HbA1c) decreased from 7.74 ± 1.71 % to 6.43 ± 1.39 % ( -1.31 ± 0.32 %, p < 0.001) in patients with T1DM, and from 8.13 ± 1.56 % to 6.72 ± 1.40 % ( -1.41 ± 0.28 %, p < 0.001) in patients with T2DM. A statistically significant (p < 0.001) increase in the number of patients with HbA1c < 5.4 % was further demonstrated. The decrease in fasting
blood glucose (FBG) and 6-point
blood sugar profile was also statistically significant in both types of diabetes (p < 0.001). Changes in
therapy and subsequent treatment with
insulin glargine were perceived positively by both physicians and patients.
CONCLUSION: