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Clinical Drug Investigation

, Volume 33, Issue 4, pp 263–274 | Cite as

A Multinational, Observational Study to Investigate the Efficacy, Safety and Tolerability of Acarbose as Add-On or Monotherapy in a Range of Patients: The GlucoVIP Study

  • Weiwei Zhang
  • DongJun Kim
  • Elizabeth Philip
  • Zahid Miyan
  • Irina Barykina
  • Birgit Schmidt
  • Herbert Stein
Original Research Article

Abstract

Background and Objectives

The burden of type 2 diabetes mellitus is growing rapidly, particularly in the Asia-Pacific region. The aim of this international, large-scale, observational study was to investigate the efficacy and tolerability of the antidiabetic agent acarbose as add-on or monotherapy in a range of patients with type 2 diabetes, including those with cardiovascular morbidities. The majority of practices were included from high-burden regions (predominantly those in the Asia-Pacific region).

Methods

This was an observational study conducted in 15 countries/regions. Adults with pre-treated or untreated type 2 diabetes prescribed acarbose as add-on or monotherapy were eligible. Two-hour postprandial blood glucose (2-h PPG), glycosylated haemoglobin (HbA1c) and fasting blood glucose (FBG) were measured over a 3-month observation period.

Results

A total of 15,034 patients were valid for the efficacy analysis and 15,661 for the safety analysis (mean age was 57.6 years and 92.6 % of patients were Asian). Mean (SD) 2-h PPG decreased by −71.9 (62.3) mg/dL, to 170.2 (46.5) mg/dL at final visit (after 12.8 [4.1] weeks). Mean HbA1c decreased by −1.1 % (1.3) to 7.2 % (1.1) and mean FBG decreased by −33.0 (43.3) mg/dL to 124.8 (30.5) mg/dL. Acarbose was effective regardless of the presence of cardiovascular co-morbidities or diabetic complications. The efficacy of acarbose was rated ‘very good’ or ‘good’ in 85.5 % of patients, and tolerability as ‘very good’ or ‘good’ in 84.9 % of patients. Drug-related adverse events, mainly gastrointestinal, were reported in 490/15,661 patients (3.13 %).

Conclusion

The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.

Keywords

Waist Circumference Impaired Glucose Tolerance Fasting Blood Glucose Acarbose Initial Visit 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

This work was funded by a research grant from Bayer, Berlin, Germany. Editorial assistance was provided by PAREXEL, which was contracted by Bayer, Berlin, Germany.

Author Contributions

Weiwei Zhang, DongJun Kim, Elizabeth Philip, Zahid Miyan and Irina Barykina were involved in data collection and analysis, and were involved in writing and reviewing the manuscript. Herbert Stein and Birgit Schmidt were involved in the study design, data collection and analysis, and writing and reviewing the manuscript.

Conflict of interest

Herbert Stein and Birgit Schmidt are employees of Bayer HealthCare, Germany. No other authors report a conflict of interest.

Role of the Funding Source

Bayer were involved in the study design, the collection, analysis and interpretation of data, and in the decision to submit the paper for publication.

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Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • Weiwei Zhang
    • 1
  • DongJun Kim
    • 2
  • Elizabeth Philip
    • 3
  • Zahid Miyan
    • 4
  • Irina Barykina
    • 5
  • Birgit Schmidt
    • 6
  • Herbert Stein
    • 7
  1. 1.Beijing Military General HospitalBeijingChina
  2. 2.Inje University Ilsan Paik HospitalSeoulKorea
  3. 3.Kurinji HospitalNava IndiaIndia
  4. 4.Hanif HospitalKarachiPakistan
  5. 5.Volgograd Medical State UniversityVolgogradRussia
  6. 6.Bayer Vital GmbHLeverkusenGermany
  7. 7.Bayer Pharma AGBerlinGermany

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