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Efficacy and Safety of Insulin Glargine Compared to Other Interventions in Younger and Older Adults: A Pooled Analysis of Nine Open-Label, Randomized Controlled Trials in Patients with Type 2 Diabetes

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Abstract

Objective

Elderly patients with type 2 diabetes mellitus (T2DM) present therapeutic challenges related to co-morbidities, treatment adherence, and safety. This study examines the efficacy and safety of insulin glargine compared to other glucose-lowering interventions in younger and older adults.

Methods

In this pooled analysis of 24-week data from nine prospective open-label, multicenter, phase 3/4, two-arm, parallel-group, randomized controlled trials, patients with T2DM aged 18–80 years received insulin glargine (used as a basal insulin regimen) or comparators (including rosiglitazone, pioglitazone, insulin lispro, insulin lispro 75/25, NPH insulin, NPH insulin 30/70, and lifestyle/dietary measures). Endpoints included change from baseline to week 24 in: glycated hemoglobin; fasting plasma glucose; body weight; body mass index; insulin dose; incidence of nocturnal, daytime, or any hypoglycemia. Results were stratified by age (<65, ≥65, 65–74, and ≥75 years) and treatment (insulin glargine or comparator).

Results

A total of 2,938 patients were included (2,263 aged <65 years, 675 aged ≥65 years). Similar levels of glycemic control were achieved in both younger (<65 years) and older (≥65 years) patients with T2DM. Insulin glargine was associated with better glycemic control and a reduced incidence of daytime and any hypoglycemia versus comparator interventions in both younger and older T2DM patients.

Conclusion

This analysis suggests that insulin glargine may represent a safe option to improve glycemic control in older patients with T2DM.

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Acknowledgements

Funding This study was funded by Sanofi US, Inc. The authors received writing/editorial support in the preparation of this manuscript provided by Pim Dekker, PhD, of Excerpta Medica, funded by Sanofi US, Inc.

Sponsor’s role

This study was funded by Sanofi US, Inc., and was a pooled analysis of data from randomized controlled trials (13–20, Data on file, HOE-901-4021). The writing/editorial support received by the authors in the preparation of this manuscript was funded by Sanofi US, Inc.

Conflict of interest

Pandya: speaker for Sanofi US, Inc. and Novo Nordisk, received consultation fees from Sanofi. DiGenio: employee of Sanofi US, Inc. Gao: Senior statistical consultant for Sanofi US Inc., Analystat Inc. Patel: speaker for Sanofi US, Inc., received research grant from Takeda.

Author contributions

Pandya: Provided clinical expertise in the interpretation of the data and its clinical relevance, critically revised the manuscript outline and draft, provided comments and provided final approval of the manuscript.

DiGenio: Proposed and developed the concept, interpreted the results of the analyses, critically revised the manuscript outline and draft, provided comments and provided final approval of the manuscript.

Gao: Collected the data, developed the analysis plan, conducted statistical analysis and prepared tables with results, critically revised the manuscript outline and draft, provided comments and provided final approval of the manuscript.

Patel: Provided clinical expertise in the interpretation of the data and its clinical relevance, critically revised the manuscript outline and draft, provided comments and provided final approval of the manuscript.

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Authors and Affiliations

  1. Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, 3200 S University Dr, Terry Building, Rm 1473, Davie, FL, 33328, USA

    Naushira Pandya

  2. Sanofi US, Inc., Bridgewater, NJ, USA

    Andres DiGenio

  3. Analystat Inc., Belle Mead, NJ, USA

    Ling Gao

  4. Boonshoft School of Medicine, Wright State University, Dayton, OH, USA

    Meenakshi Patel

Authors
  1. Naushira Pandya
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  2. Andres DiGenio
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  3. Ling Gao
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  4. Meenakshi Patel
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Correspondence to Naushira Pandya.

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Pandya, N., DiGenio, A., Gao, L. et al. Efficacy and Safety of Insulin Glargine Compared to Other Interventions in Younger and Older Adults: A Pooled Analysis of Nine Open-Label, Randomized Controlled Trials in Patients with Type 2 Diabetes. Drugs Aging 30, 429–438 (2013). https://doi.org/10.1007/s40266-013-0069-9

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