The online version of this article (doi:10.1186/s12902-015-0051-0) contains supplementary material, which is available to authorized users.
Thomas Danne (TD), Tobias Bluhmki (TB), Jochen Seufert (JS), Matthias Kaltheuner (MK), Wolfgang Rathmann (WR), Jan Beyersmann (JB) and Peter Bramlage (PB) have no potential conflict of interest to disclose.
TD, MK, WR, and PB designed the registry. TB, PB, and JB outlined the analyses, which were performed by TB. PB and TB drafted the first version of the manuscript, which all other authors revised for important intellectual content. All authors approved the final version of the manuscript that was submitted.
In patients with type-2 diabetes receiving oral antidiabetic drugs (OADs), the addition of insulin is frequently required to achieve sufficient control over blood glucose levels. It is, however, difficult to predict if, when and in which patients insulin therapy will be needed. We aimed to identify patient related variables associated with the addition of basal insulin to oral therapy resulting in a basal supported oral therapy (BOT).
DIVE (DIabetes Versorgungs-Evaluation) is a prospective, observational, multi-centre diabetes registry established in Germany in 2011. For the present explorative analysis, 31,008 patients with type-2 diabetes prescribed at least one OAD were included. Patients who had previously received insulin and those over 90 years old were excluded. The event of interest was defined as the initiation of BOT during the observational period. Cause-specific Cox proportional hazards models based on a competing risk framework were applied for risk quantification.
Multivariable adjusted hazard ratios demonstrated that longer diabetes duration, higher BMI, poorer glycaemic control, documentation of any micro- or macrovascular comorbidity, the presence of concomitant non-antidiabetic pharmacotherapies, and greater numbers of prescribed OADs increased the likelihood of BOT initiation. On the other hand BOT initiation was less likely in patients with older age and female gender. Analysing the likelihood of OAD termination without initiation of BOT provided supportive evidence for the variables predictive of BOT initiation.
Analysis of the DIVE registry has resulted in the identification of a number of factors that may be predictive for the initiation of BOT for type-2 diabetes patients initially prescribed one or more OADs. Poor glycaemic control, the presence of vascular comorbidities and concomitant medications, and a greater number of OADs were all detected to increase the risk of a switch to BOT. Female gender and younger age showed protective properties.
The close monitoring of patients displaying these characteristics may help to identify individuals who might benefit from early addition of insulin therapy to their oral treatment regimen.
Additional file 1: Table S1. Concomitant pharmacotherapy: ATC indices*. Legend: DDP-4, dipeptidyl peptidase-4. *World Health Organisation Collaborating Centre for Drugs Statistics Methodology. (DOCX 14 kb)12902_2015_51_MOESM1_ESM.docx
Additional file 2: Table S2. Absolute Number of Missing Values and Relative Proportion w.r.t. total study population. (DOCX 14 kb)12902_2015_51_MOESM2_ESM.docx
Additional file 3: Table S3. Predictors of switch to BOT: Multivariate HRs and corresponding lower and upper bounds of the 95 % CIs including only patients with complete covariate information. (DOCX 16 kb)12902_2015_51_MOESM3_ESM.docx
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