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Characteristics of Patients with Type-1 or Type-2 Diabetes Receiving Insulin Glargine U300: An Analysis of 7268 Patients Based on the DPV and DIVE Registries

Abstract

Introduction

Insulin glargine 300 U/ml (U300) was registered based on the EDITION clinical trial program. The aim of this database analysis was to describe the profile of adult U300 recipients with type-1 (T1DM) or type-2 diabetes (T2DM).

Methods

The analysis was based on data from the German DIVE/DPV registries. Patients were sampled in May (DIVE) and in March 2018 (DPV) and divided into those who commenced U300 within the 1st year (early adopters) or 2nd year (late adopters). Patients were further compared to patients receiving U100 during the same time period.

Results

Among 581,519 adult patients contained in the databases, 7268 with either T1 or T2DM received U300 and 22,050 U100. Baseline characteristics of U300 and U100 recipients did not differ substantially in both types of diabetes. Patients with T2DM had many risk factors and comorbidities. The median HbA1c (both T1DM and T2DM, 8.1% for U300 and 7.9 and 8.3% for U100) and fasting blood glucose values were similar at baseline. Severe hypoglycemia was less prevalent in T2DM and among recipients of U300 (3.1 vs. 3.9%), whereas in T1DM the rate was higher (10.6 vs. 10.1%). There were minor, but clinically probably irrelevant, differences in age and BMI for T1DM and T2DM between the first and second years. Patients with T2DM being initiated in the second year had a higher HbA1c value (8.6 vs. 8.3%) than those initiated during the first year. Patients in clinical practice showed substantially higher HbA1c values in both T1DM and T2DM, and doses used were lower than those reported from the EDITION trial program. U300 patients had a longer diabetes duration (T1 and T2DM), a higher BMI and received higher basal insulin doses (T1 and T2DM) compared to U100. While HbA1c was comparable, the rate of severe hypoglycemia under U300 was reduced in T2DM but not T1DM with or without adjustment for differences in baseline characteristics in T2DM.

Conclusion

The data confirm the clinical profile documented for U300 in the EDITION studies during the first years of its registration. In an unselected patient population, there was a lesser rate of severe hypoglycemia but at a comparable HbA1c.

Funding

German Centre for Diabetes Research (DZD) (01GI1106), the European Foundation for the Study of Diabetes (EFSD) and the German Diabetes Society (DDG). The DIVE registry (organized as Diabetes Agenda 2010 GmbH, Berlin, Germany) received funding from Sanofi, AstraZeneca, Bayer, and Abbott and was conducted under the auspices of diabetesDE.

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Acknowledgements

We thank all participating centers of the DPV and DIVE initiatives. The DPV initiative was approved by the University of Ulm Ethics Committee and data collection was approved by local review boards (process number 202/09). The DIVE research protocol was approved by the Hannover Medical School Ethics Committee (process number 6003).

Funding

The DPV registry was supported by the German Centre for Diabetes Research (DZD) (01GI1106), the European Foundation for the Study of Diabetes (EFSD) and the German Diabetes Society (DDG). The DIVE registry (organized as Diabetes Agenda 2010 GmbH, Berlin, Germany) received funding from Sanofi, AstraZeneca, Bayer, and Abbott and was conducted under the auspices of diabetesDE. Funders were not involved in study design, the collection, analysis and interpretation of data, the writing of the report or the decision to submit the article for publication. Diabetes Agenda 2010 GmbH is the legal sponsor of the DIVE project and funded the journal’s article processing charges.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

SS, FP, MD, MB, and TD contributed to the data collection. GvM and PB designed the analysis, drafted the manuscript and created figures. SL and RWH did the statistical analyses. SL, SS, FP, MD, MB, TD, JS and RWH contributed to the discussion and reviewed/edited the manuscript. SL and RWH had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Disclosures

Thomas Danne reports grant and honoraria from Abbott, AstraZeneca, and Sanofi, outside the submitted work. Jochen Seufert reports grant and honoraria from Abbott, AstraZeneca, and Sanofi, outside the submitted work. Peter Bramlage reports to have received consultancy honoraria from Sanofi and Abbott. Gesine van Mark, Stefanie Lanzinger, Stefan Sziegoleit, Franz Josef Putz, Mesut Durmaz, Michaela Borscheller and Reinhard W. Holl have nothing to declare.

Compliance with Ethics Guidelines

The research protocol was approved by the Hannover Medical School Ethics Committee and all patients provided written informed consent. Springer’s policy concerning informed consent has been followed. The registry was conducted in line with the Helsinki Declaration of 1964, as revised in 2013, concerning human and animal rights.

Data Availability

The dataset generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Correspondence to Peter Bramlage.

Additional information

Reinhard W. Holl and Peter Bramlage shared senior authorship.

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van Mark, G., Lanzinger, S., Sziegoleit, S. et al. Characteristics of Patients with Type-1 or Type-2 Diabetes Receiving Insulin Glargine U300: An Analysis of 7268 Patients Based on the DPV and DIVE Registries. Adv Ther 36, 1628–1641 (2019). https://doi.org/10.1007/s12325-019-00983-w

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Keywords

  • Antidiabetic drugs
  • Diabetes
  • Insulin glargine 300 U/ml
  • Real-world evidence
  • Type-1 diabetes
  • Type-2 diabetes