2 research outputs found
Intensification of insulin therapy in patients with type 2 diabetes: a retrospective, non- interventional cohort study of patients treated with insulin glargine or biphasic human insulin in daily clinical practice
Intensification of insulin therapy in patients with type 2 diabetes: a retrospective, non- interventional cohort study of patients treated with insulin glargine or biphasic human insulin in daily clinical practice
Background: The aim of this study is to compare the efficacy of
intensification of insulin treatment with insulin glargine and biphasic
human insulin in patients with type 2 diabetes on concomitant therapy
with oral antidiabetic drugs (OAD) in daily clinical practice.
Methods: A retrospective multicentre parallel two-arm study included 301
patients with type 2 diabetes already on treatment with biphasic human
insulin twice daily (bd) in combination with OAD. Data were collected
retrospectively from 142 patients who had been switched from biphasic
human insulin to insulin glargine in a period of 6-12 months prior to
their inclusion (active group) and compared to data collected
retrospectively from 159 patients who continued treatment with biphasic
human insulin bd for the same time period (control group). Our primary
objective was to examine the efficacy of the two treatments, assessed as
change in HbA1c. Secondary objectives were to examine for changes in
fasting blood glucose (FBG), body weight, treatment with OAD or
fast-acting insulin and safety, by assessing the frequency and severity
of hypoglycaemic episodes.
Results: At the end of the study there was a significant reduction in
HbA1c in both arms. The least squares (LS) mean [(95% confidence
intervals (CI)] reduction in HbA1c was -1.13 (-0.96 to -1.30)% in the
active and -0.59 (-0.41to -0.77)% in the control group [LS mean
treatment difference 0.53 (0.31-0.76)%, p < 0.001]. Similarly, fasting
blood glucose declined significantly in both arms. The LS mean decline
in FBG was -47.02 (-37.89 to -56.14) mg/dl in the active and -19.73
(-11.57 to -27.89) mg/dl in the control group [LS mean treatment
difference 27.85 (15.74-39.95) mg/dl, p < 0.001]. No significant
difference in hypoglycaemic episodes and in body weight was found. In
the active group, more patients received rapid-acting pre-meal insulin
and used insulin secretagogues drugs.
Conclusions: Glargine alone or in combination with fast acting insulin
is more effective in reducing glycaemia than biphasic human insulin
alone or in combination with fast acting insulin in patients with type 2
diabetes without increase in hypoglycaemic episodes or body weight