title: Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study.
abstract: Primary objective - evaluate effectiveness and safety of acarbose/metformin fixed dose FDC on glycemic control in Indian T2DM patients in real life clinical setting. Secondary objective - evaluate safety and satisfaction of treatment.
  
  
  METHODS
  Open-label, prospective, multicentre, single-arm, non-interventional study. Patients included were aged ≥18 years with T2DM on Acarbose (25/50 mg) and Metformin (500 mg) FDC. Glycemic parameters were recorded during observation.
  
  
  RESULTS
  Total 9364 patients were enrolled in the study (mean age, 50.7 years and 60.1% were male). Mean (SD) FBG and PPG was significantly reduced by 42.4 (32.6) mg/dl (P < 0.0001) and 80.2 (49.7) mg/dl (P < 0.0001) respectively at the end of observation. Mean (SD) HbA1c reduced by -1.0% (0.8) to 7.3% (0.7) at the last follow-up visit (P <0.0001). Majority of patients (97.5%) and physicians (98.42%) were satisfied with acarbose/metformin FDC treatment. Also, significant reduction in body weight by -1.7 (2.2) kg was observed (P < 0.0001). Patients with known T2DM and newly diagnosed showed a similar glycemic control (P < 0.0001). Drug-related adverse events were reported by only 1.4% patients mostly gastrointestinal.
  
  
  CONCLUSIONS
  Acarbose/metformin FDC was efficacious, safe well accepted in routine clinical practice. It was well-tolerated without significant risk of hypoglycemia and can be used in early T2DM management.
authors.affiliation: Consultant Physician, DiaCare Clinic, Ahmedabad, Gujarat, India.
authors.forename: Banshi
authors.initials: B
authors.lastname: Saboo
authors.affiliation: Consultant Endocrinologist, G. C. Reddy Clinic, Hyderabad, Andhra Pradesh, India.
authors.forename: Gundam Chandrasekhara
authors.initials: GC
authors.lastname: Reddy
authors.affiliation: Consultant Physician, Heart and Diabetes Care Hospital, Delhi, India.
authors.forename: Subhashchander
authors.initials: S
authors.lastname: Juneja
authors.affiliation: Consultant Physician, Ashok Kumar, Kedia Clinic, Gorakhpur, Uttar Pradesh, India.
authors.forename: Ashok Kumar
authors.initials: AK
authors.lastname: Kedia
authors.affiliation: Medical Affairs, Bayer Zydus Pharma, Mumbai, Maharashtra, India.
authors.forename: Pravin
authors.initials: P
authors.lastname: Manjrekar
authors.affiliation: Medical Affairs, Bayer Zydus Pharma, Mumbai, Maharashtra, India.
authors.forename: Rahul
authors.initials: R
authors.lastname: Rathod
keywords: Acarbose; HbA1c; India; Type 2 diabetes mellitus; alpha glucosidase inhibitor; combination; metformin; postprandial glucose