Abstract
Objective and design
This post-marketing surveillance study collected data on the efficacy and tolerability of acarbose in patients with insulin-treated type 2 diabetes mellitus and, in particular, on its effect on postprandial blood glucose under normal daily practice conditions.
Patients and methods
A total of 1142 patients were included in this observational study in which the treating physicians had sole responsibility for determining acarbose doses and other therapeutic measures. Efficacy parameters consisted of fasting and postprandial blood glucose and glycosylated haemoglobin (HbA1c). Additionally, cholesterol, triglycerides and weight were analysed. All patient data had to be recorded by the attending physician on a case report form. Patients were asked to self-monitor blood glucose daily after breakfast (1h) and to keep a diary.
Results
Mean HbA1c improved by 0.9%, fasting blood glucose by 32.4 mg/dL, and postprandial hyperglycaemia by 49.7 mg/dL during the observation period compared with baseline. Comparable results were obtained in combination with conventional, functional or intensive insulin therapy. Mean weight was reduced by 0.7kg. The incidence of acarbose-related side effects was low (6.9%) and consisted mostly of gastrointestinal complaints. The majority of patients assessed acarbose treatment positively.
Conclusion
The addition of acarbose to different insulin regimens provided an efficacious and safe treatment for better glycaemic and weight control.
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Acknowledgements
The concept of this post-marketing surveillance study was developed and funded by Bayer Vital GmbH, Leverkusen, Germany. Statistical analyses were performed by the Institute KFM, Munich. We would like to thank all the physicians who participated in this surveillance study for their excellent cooperation.
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Klocke, K.R., Stauch, K. & Landen, H. Effect of Add-On Acarbose to Insulin Therapy in Routine Clinical Practice. Clin. Drug Investig. 23, 621–627 (2003). https://doi.org/10.2165/00044011-200323100-00001
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DOI: https://doi.org/10.2165/00044011-200323100-00001