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Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):129-35. doi: 10.4103/2230-8210.146868.

Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study.

Author information

1
Consultant Physician, DiaCare Clinic, Ahmedabad, Gujarat, India.
2
Consultant Endocrinologist, G. C. Reddy Clinic, Hyderabad, Andhra Pradesh, India.
3
Consultant Physician, Heart and Diabetes Care Hospital, Delhi, India.
4
Consultant Physician, Ashok Kumar, Kedia Clinic, Gorakhpur, Uttar Pradesh, India.
5
Medical Affairs, Bayer Zydus Pharma, Mumbai, Maharashtra, India.

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.

MATERIALS AND 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.

KEYWORDS:

Acarbose; HbA1c; India; Type 2 diabetes mellitus; alpha glucosidase inhibitor; combination; metformin; postprandial glucose

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