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


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).


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.


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 %).


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.


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.



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.


  1. 1.
    IDF Diabetes Atlas. International Diabetes Federation. 5th ed. Accessed 5 Jan 2012.
  2. 2.
    Roglic G, Unwin N, Bennett PH, et al. The burden of mortality attributable to diabetes: realistic estimates for the year 2000. Diabetes Care. 2005;28(9):2130–5.PubMedCrossRefGoogle Scholar
  3. 3.
    Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. N Engl J Med. 2000;342(6):381–9.Google Scholar
  4. 4.
    Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):837–53.Google Scholar
  5. 5.
    Liu Z, Fu C, Wang W, et al. Prevalence of chronic complications of type 2 diabetes mellitus in outpatients—a cross-sectional hospital based survey in urban China. Health Qual Life Outcomes. 2010;8:62.PubMedCrossRefGoogle Scholar
  6. 6.
    Choi YJ, Kim HC, Kim HM, et al. Prevalence and management of diabetes in Korean adults: Korea National Health and Nutrition Examination Surveys 1998–2005. Diabetes Care. 2009;32(11):2016–20.PubMedCrossRefGoogle Scholar
  7. 7.
    Alberti KG, Zimmet P, Shaw J. International Diabetes Federation: a consensus on Type 2 diabetes prevention. Diabet Med. 2007;24(5):451–63.PubMedCrossRefGoogle Scholar
  8. 8.
    Hanefeld M, Fischer S, Julius U, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996;39(12):1577–83.PubMedCrossRefGoogle Scholar
  9. 9.
    DECODE Study Group on behalf of the European Diabetes Epidemiology Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001;161(3):397–405.CrossRefGoogle Scholar
  10. 10.
    Meigs JB, Nathan DM, D’Agostino RB Sr, et al. Fasting and postchallenge glycemia and cardiovascular disease risk: the Framingham Offspring Study. Diabetes Care. 2002;25(10):1845–50.PubMedCrossRefGoogle Scholar
  11. 11.
    Levitan EB, Song Y, Ford ES, et al. Is nondiabetic hyperglycemia a risk factor for cardiovascular disease? A meta-analysis of prospective studies. Arch Intern Med. 2004;164(19):2147–55.PubMedCrossRefGoogle Scholar
  12. 12.
    Nakagami T, DECODA Study Group. Hyperglycaemia and mortality from all causes and from cardiovascular disease in five populations of Asian origin. Diabetologia. 2004;47(3):385–94.PubMedCrossRefGoogle Scholar
  13. 13.
    Monnier L, Colette C, Boniface H. Contribution of postprandial glucose to chronic hyperglycaemia: from the “glucose triad” to the trilogy of “sevens”. Diabetes Metab. 2006;32(Spec. No 2):2S11–6.Google Scholar
  14. 14.
    Woerle HJ, Neumann C, Zschau S, et al. Impact of fasting and postprandial glycemia on overall glycemic control in type 2 diabetes Importance of postprandial glycemia to achieve target HbA1c levels. Diabetes Res Clin Pract. 2007;77(2):280–5.PubMedCrossRefGoogle Scholar
  15. 15.
    Peter R, Okoseime OE, Rees A, et al. Postprandial glucose—a potential therapeutic target to reduce cardiovascular mortality. Curr Vasc Pharmacol. 2009;7(1):68–74.PubMedCrossRefGoogle Scholar
  16. 16.
    Wang JS, Tu ST, Lee IT, et al. Contribution of postprandial glucose to excess hyperglycaemia in Asian type 2 diabetic patients using continuous glucose monitoring. Diabetes Metab Res Rev. 2011;27(1):79–84.PubMedCrossRefGoogle Scholar
  17. 17.
    Ceriello A, Hanefeld M, Leiter L, et al. Postprandial glucose regulation and diabetic complications. Arch Intern Med. 2004;164(19):2090–5.PubMedCrossRefGoogle Scholar
  18. 18.
    2011 Guideline for Management of PostMeal Glucose in Diabetes. International Diabetes Federation. Accessed 3 Feb 2011.
  19. 19.
    Derosa G, Maffioli P. Efficacy and safety profile evaluation of acarbose alone and in association with other antidiabetic drugs: a systematic review. Clin Ther. 2012;34:1221–36.PubMedCrossRefGoogle Scholar
  20. 20.
    DECODE Study Group, the European Diabetes Epidemiology Group. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. The DECODE study group. European Diabetes Epidemiology Group. Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe. Lancet. 1999;354(9179):617–21.CrossRefGoogle Scholar
  21. 21.
    The DECODA Study Group. Hyperglycaemia and mortality from all causes and from cardiovascular disease in five populations of Asian origin. Diabetologia. 2004;47:385–94.CrossRefGoogle Scholar
  22. 22.
    Cavalot F, Pagliarino A, Valle M, et al. Postprandial blood glucose predicts cardiovascular events and all-cause mortality in type 2 diabetes in a 14-year follow-up: lessons from the San Luigi Gonzaga Diabetes Study. Diabetes Care. 2011;34(10):2237–43.PubMedCrossRefGoogle Scholar
  23. 23.
    Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003;26(3):881–5.PubMedCrossRefGoogle Scholar
  24. 24.
    Spengler M, Schmitz H, Landen H. Evaluation of the efficacy and tolerability of acarbose in patients with diabetes mellitus : a postmarketing surveillance study. Clin Drug Investig. 2005;25(10):651–9.PubMedCrossRefGoogle Scholar
  25. 25.
    Mertes G. Safety and efficacy of acarbose in the treatment of Type 2 diabetes: data from a 5-year surveillance study. Diabetes Res Clin Pract. 2001;52(3):193–204.PubMedCrossRefGoogle Scholar
  26. 26.
    Li C, Hung YJ, Qamruddin K, et al. International noninterventional study of acarbose treatment in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2011;92(1):57–64.PubMedCrossRefGoogle Scholar
  27. 27.
    Derosa G, Maffioli P, Ferrari I, et al. Acarbose actions on insulin resistance and inflammatory parameters during an oral fat load. Eur J Pharmacol. 2011;651(1–3):240–50.PubMedCrossRefGoogle Scholar
  28. 28.
    Derosa G, Maffiolo P, D’Angelo A, et al. Acarbose on insulin resistance after an oral fat load: a double-blind, placebo controlled study. J Diabetes Complicat. 2011;25(4):258–66.PubMedCrossRefGoogle Scholar
  29. 29.
    Derosa G, Salvadeo SA, D’Angelo A, et al. Metabolic effect of repaglinide or acarbose when added to a double oral antidiabetic treatment with sulphonylureas and metformin: a double-blind, cross-over, clinical trial. Curr Med Res Opin. 2009;25(3):607–15.PubMedCrossRefGoogle Scholar
  30. 30.
    Derosa G, D’Angelo A, Salvadeo SA, et al. Modulation of adipokines and vascular remodelling markers during OGTT with acarbose or pioglitazone treatment. Biomed Pharmacother. 2009;63(10):723–33.PubMedCrossRefGoogle Scholar
  31. 31.
    Derosa G, Mereu R, D’Angelo A, et al. Effect of pioglitazone and acarbose on endothelial inflammation biomarkers during oral glucose tolerance test in diabetic patients treated with sulphonylureas and metformin. J Clin Pharm Ther. 2010;35(5):565–79.PubMedCrossRefGoogle Scholar
  32. 32.
    American Diabetes Association. Standards of medical care in diabetes—2011. Diabetes Care. 2011;34(Suppl 1):S11–61.Google Scholar
  33. 33.
    Hoffmann J, Spengler M. Efficacy of 24-week monotherapy with acarbose, glibenclamide, or placebo in NIDDM patients. The Essen Study. Diabetes Care. 1994;17(6):561–6.PubMedCrossRefGoogle Scholar
  34. 34.
    Hoffmann J, Spengler M. Efficacy of 24-week monotherapy with acarbose, metformin, or placebo in dietary-treated NIDDM patients: the Essen-II Study. Am J Med. 1997;103(6):483–90.PubMedCrossRefGoogle Scholar
  35. 35.
    Pan C, Yang W, Barona JP, et al. Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial. Diabet Med. 2008;25(4):435–41.PubMedCrossRefGoogle Scholar
  36. 36.
    Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359(9323):2072–7.PubMedCrossRefGoogle Scholar
  37. 37.
    Chiasson JL, Josse RG, Gomis R, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA. 2003;290(4):486–94.PubMedCrossRefGoogle Scholar
  38. 38.
    Chiasson JL. Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial. Endocr Pract. 2006;12(Suppl 1):25–30.PubMedCrossRefGoogle Scholar
  39. 39.
    Hanefeld M, Cagatay M, Petrowitsch T, et al. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: meta-analysis of seven long-term studies. Eur Heart J. 2004;25(1):10–6.PubMedCrossRefGoogle Scholar
  40. 40.
    Hanefeld M. Cardiovascular benefits and safety profile of acarbose therapy in prediabetes and established type 2 diabetes. Cardiovasc Diabetol. 2007;6:20.PubMedCrossRefGoogle Scholar
  41. 41.
    Spengler M, Cagatay M. The use of acarbose in the primary-care setting: evaluation of efficacy and tolerability of acarbose by postmarketing surveillance study. Clin Invest Med. 1995;18(4):325–31.PubMedGoogle Scholar
  42. 42.
    Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545–59.PubMedCrossRefGoogle Scholar
  43. 43.
    Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:b4909.PubMedCrossRefGoogle Scholar
  44. 44.
    Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med. 2008;358(24):2630–3.PubMedCrossRefGoogle Scholar
  45. 45.
    Holstein A, Egberts EH. Risk of hypoglycaemia with oral antidiabetic agents in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2003;111(7):405–14.PubMedCrossRefGoogle Scholar
  46. 46.
    Fach information: Glucobay 50 mg, Glucobay 100 mg. 2010. Document 003443-D671 DE/28.Google Scholar

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

Personalised recommendations