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
- 424 Downloads
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.
KeywordsWaist Circumference Impaired Glucose Tolerance Fasting Blood Glucose Acarbose Initial Visit
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.
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.IDF Diabetes Atlas. International Diabetes Federation. 5th ed. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed 5 Jan 2012.
- 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.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
- 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
- 18.2011 Guideline for Management of PostMeal Glucose in Diabetes. International Diabetes Federation. http://www.idf.org/sites/default/files/postmeal%20glucose%20guidelines.pdf. Accessed 3 Feb 2011.
- 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
- 32.American Diabetes Association. Standards of medical care in diabetes—2011. Diabetes Care. 2011;34(Suppl 1):S11–61.Google Scholar
- 46.Fach information: Glucobay 50 mg, Glucobay 100 mg. 2010. Document 003443-D671 DE/28.Google Scholar