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Insulin glargine benefits patients with type 2 diabetes inadequately controlled on oral antidiabetic treatment: an observational study of everyday practice in 12,216 patients
Author(s) -
Schreiber S. A.,
Haak T.
Publication year - 2007
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2006.00593.x
Subject(s) - insulin glargine , observational study , medicine , type 2 diabetes , diabetes mellitus , insulin , intensive care medicine , endocrinology
Aims: This observational study aimed to investigate the long‐term efficacy and safety of adding insulin glargine (LANTUS ® ) to support oral antidiabetic (OAD) treatment in patients with type 2 diabetes in everyday practice. Methods: A 9‐month, open‐label, multicentre, observational study, with an optional 20‐month extension phase, in which add‐on insulin glargine therapy was initiated in 12,216 patients with type 2 diabetes inadequately controlled on OADs. The insulin glargine dose was adjusted at the physician’s discretion, reflecting everyday practice. The main outcome measures were changes in HbA 1c , fasting blood glucose (FBG), insulin dose and body mass index (BMI). Results: At baseline, mean (± s.d.) age was 63.9 ± 11.3 years; disease duration was >5 years in 47% of patients, 1–5 years in 39% of patients and <1 year in 10% of patients, while 4% of patients were newly diagnosed. Addition of insulin glargine to OAD therapy led to reductions in mean HbA 1c (−1.5% from 8.7%) and FBG (−69 mg/dl from 202 mg/dl) levels after 3 months, which were maintained after 9 months [HbA 1c : −1.7%; FBG: −71 mg/dl (−3.9 mmol/l)] without an increase in BMI. Similar glycaemic control was observed after 20 months in the 2721 patients in the extension study. Adverse drug reactions were documented in 26 patients (0.2%). Of 47 adverse events documented, 19 were due to hypoglycaemia. Conclusions: In everyday practice, patients with type 2 diabetes who are inadequately controlled on OADs benefit from add‐on basal insulin treatment with insulin glargine as they demonstrate improved glycaemic control without weight gain.