Characteristics of patients with type 2 diabetes mellitus initiating insulin therapy: baseline data from the INSTIGATE study

Objective: To describe the characteristics at baseline of patients with type 2 diabetes mellitus who are initiating insulin. Methods: Prospective, observational multi-centre, open-label study in five European countries of patients with type 2 diabetes who were initiating insulin as part of their usual care. Results: A total of 1172 patients were enrolled, with mean age 63.3 years and body mass index 29.9 kg/m(2). The majority (90%) of patients were taking one or more oral anti-diabetic agents; the percentage not taking anti-diabetic medication in the previous four weeks was highest in Germany (23.4%) and Spain (15.1%). The prevalence of microvascular diseases (range: 16.1%-36.1%) varied considerably between countries but for macrovascular (30.4%-38.6%) and other diabetes-related diagnoses (72.6%-76.6%) such as hypertension and dyslipidaemia the differences were less pronounced. In Germany, reported use of lipid-lowering (26.7%) and anti-platelet (27.1%) therapies was much less than in other countries (ranges: 53.2%-78.1% and 48.3%-61.1%, respectively). The majority of evaluable patients in each country had demonstrated poor control over a long period of time. Prior to initiating insulin, the most recent mean (+/-SD) HbA1(c) was 9.58 +/- 1.81%, fasting plasma glucose was 12.18 +/- 4.32 mmol/L and 78.5% had metabolic syndrome. IDF targets for HDL- and LDL-cholesterol, and blood pressure were met in 76.8%, 33.1% and 18.9% of patients, respectively. Conclusions: Insulin treatment was only initiated after HbA1(c) values were considerably higher than recommended in treatment guidelines for a sustained period of time.