Real-world insulin therapy in German type 2 diabetes mellitus patients: patient characteristics, treatment patterns, and insulin dosage

Abstract

Background

A substantial share of type 2 diabetes mellitus (T2DM) patients receive insulin. However, little is known about the real-world treatment patterns around insulin initiation.

Methods

This was a retrospective claims data analysis. T2DM patients who initiated an insulin therapy between 01/01/2013 and 31/12/2015 were identified in the German AOK PLUS dataset. For validation of results, additional data on a similar T2DM patient population were collected in a Germany-wide medical chart review.

Results

A total of 284,878 T2DM patients were identified. Of these, 27,340 (9.6%) initiated an insulin treatment during the inclusion period (mean age: 72.2 years; 51.4% female). Mean/median weight and BMI of patients with available clinical data was 85.8/84.0 kg (SD:18.9) and 30.6/29.8 kg/m² (SD:6.1), respectively at baseline. Mean/median HbA1c-value at baseline was 8.4/8.0% (SD: 1.8). Most commonly prescribed antidiabetic drugs (AD) within 6 months before insulin initiation were metformin (MET; 54.0%), DPP-4 inhibitors (DPP-4i; 37.6%), and sulfonylureas (SU; 29.5%). As high as 23.2% of the patients did not receive any AD prescription within 6 months before insulin initiation. A total of 10,953 of above 27,340 insulin starters (40.1%) initiated their insulin therapy without concomitant ADs (insulin monotherapy); 43% of these patients did not receive any AD before insulin initiation. Of the remaining 16,387 patients (59.9%), 4070 patients (14.9%) received MET only as concomitant AD, 6385 (23.4%) received MET plus at least one further AD, and 5932 (21.7%) received at least one further AD excluding MET. Throughout the first year of treatment, prescribed insulin dosage increased over time, resulting in approximately 43.3–77.9 IUs per observed patient day after 12 months of insulin treatment.

Conclusions

Characteristics of German T2DM patients initiating insulin deviate substantially from the average German population, especially in terms of weight. We identified an unexpectedly high number of patients without previous AD therapy receiving insulin monotherapy, which is not in line with the clinical guidelines.

Keywords:

• T2DM
• antidiabetic treatment
• claims data
• chart review

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Real-world insulin therapy in German type 2 diabetes mellitus patients: patient characteristics, treatment patterns, and insulin dosage [Corrigendum]

Acknowledgments

The study was funded by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.

Abbreviation list

AD, antidiabetic drug; aDCSI, adapted diabetes complications severity index; BMI, body mass index; CCI, Charlson comorbidity index; DDD, defined daily dose; DDP-4i, dipeptidyl peptidase inhibitor; DIMDI, German institute of medical documentation and information; DMP, disease management program; GLP-1-RA, Glucagon-like peptide receptor antagonist; GP, general practitioners; IDF, international diabetes federation; IU, international unit; MCR, medical chart review; MET, metformin; SD, standard deviation; SGLT-2i, sodium–glucose cotransporter 2 inhibitors; SU, sulfonylureas; T1DM, type-1 diabetes mellitus; T2DM, type-2 diabetes mellitus.

Ethical approval

The study was approved by the Ethics Committee of the Faculty of Medicine, University of Rostock and the Saxon State Ministry for Social Welfare and Consumer Protection in accordance to § 75 SGB X.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary materials

Table S1 Adapted Diabetes Complications Severity Index (aDCSI)

Table S2 Charlson-Comorbidity-Score (CCI) and components

Table S3 Initiated insulin regimen according to medical chart review

Figure S1 Insulin dosage – sensitivity analysis with 180-day supply gap.

Notes: Estimated daily insulin doses compared across subgroups. The figure is showing dose estimates for the respective subgroups assuming an extended insulin supply gaps of at minimum 180 days. A patient is excluded from these estimates if he/she exceeds a supply gap of 180 days.
Abbreviations: AD, antidiabetic drug; IU, insulin units; MET, metformin; N, patient number.

Disclosure

Thomas Wilke participated in this study as a staff member of IPAM and received honoraria from several pharmaceutical/consultancy companies (Novo Nordisk, Abbvie, Merck, GSK, BMS, LEO Pharma, Astra Zeneca, Bayer, Boehringer Ingelheim, Pharmerit). Maximilian Gabler, Silke Geier, and Johannes Foersch are employed at Boehringer Ingelheim Pharma GmbH & Co. KG. Sabrina Mueller and Nils Picker participated in this study as staff members of Ingress-Health; the work of Ingress-Health in this study was financed by Boehringer Ingelheim. Jens Aberle, Stephan Martin, and Matthias Riedl participated as clinical advisors in the steering committee of this study and received honoraria and reimbursement of travel costs from Boehringer Ingelheim. Furthermore, Stephan Martin received external funding for research projects from Boehringer Ingelheim. He also reports personal fees from Boehringer Ingelheim, during the conduct of the study. He received grants, personal fees from Almased, Deutsches Institut für Telemedizin und Gesundheitsförderung, and Astra Zeneca, outside the submitted work. Jens Aberle reports grants, personal fees from Lilly, Novo Nordisk, Boehringer Ingelheim, during the conduct of the study. He also reports personal fees from Novo Nordisk, Lilly, and Boehringer Ingelheim, outside the submitted work. The authors report no other conflicts of interest in this work.