[Show abstract][Hide abstract] ABSTRACT: Objective: To assess the predictors for the initiation of a basal supported oral therapy (BOT) in type 2 diabetic patients under real-life conditions in Germany. Research design and methods: A historical cohort study based on representative German real-life data (IMS® Disease Analyzer) was performed. The study included patients with type 2 diabetes who started an oral antidiabetic drug (OAD) treatment between 01/1995 and 06/2006. Patients with consecutive treatment data for at least 12 months before and 36 months after the initiation of an OAD treatment were eligible for the analysis. The time-dependent rate of patients starting an insulin therapy with a long-acting insulin was calculated by use of the Kaplan-Meier method. Uni-and multivariate Cox regression analyses were applied to identify associated factors. Results: The study included 9,028 patients with type 2 diabetes mellitus having started an OAD therapy. 1,450 patients were switched to BOT during the observational period. The probability of initiating an insulin therapy was associated with three main predictors such as (1) poor metabolic control, (2) midlife age and (3) number and type of the OAD before insulinization. The combined Cox regression analysis led to the identification of three groups of particular importance: group I (hazard ratio [HR] = 2.72; p<0.001): HbA 1c>8 %, age 51-60 years, last OAD prescribed was a sulfonylurea, an alpha-glucosidase inhibitor or a glinide; group II (HR=2.62; p=0.032): HbA1c>8 %, age ≤50 years and pre-treatment with at least three OADs; group III (HR=2.10; p<0.019): HbA1c>8 %, pre-treatment with a combination of at least three OADs; last OAD prescribed was a sulfonylurea, an alpha-glucosidase inhibitor or a glinide. The variation of the HbA1c threshold to HbA1c≥7.5 % led to comparable outcomes, although not all groups showed a significant HR. Conclusion: The highest probability of initiating a basal supported oral therapy (BOT) under real-life conditions was found for patients with poor metabolic control, midlife age and pre-treatment with specific OADs such as sulfonylureas, alpha-glucosidase inhibitors or glinides before initiation of insulin therapy.