Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients

Results from observational GLOBE Study

behalf of GLOBE Investigators

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)129-135
Number of pages7
JournalIndian Journal of Endocrinology and Metabolism
Volume19
Issue number1
DOIs
Publication statusPublished - 01-01-2015

Fingerprint

Acarbose
Metformin
Type 2 Diabetes Mellitus
Observational Studies
Safety
Observation
Drug-Related Side Effects and Adverse Reactions
Hypoglycemia
Body Weight
Physicians
Therapeutics

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{c082a6ff10104b80961eaf993e470129,
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. 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.",
author = "{behalf of GLOBE Investigators} and Banshi Saboo and Reddy, {Gundam Chandrasekhara} and Subhashchander Juneja and Kedia, {Ashok Kumar} and Pravin Manjrekar and Rahul Rathod and S. Abdul and Acharya, {P. N.} and A. Agarwal and A. Agarwal and N. Agarwal and R. Agarwal and B. Agarwala and S. Aghao and V. Ajit and H. Ali and K. Amichandwala and Anand, {N. N.} and R. Anilkumar and G. Aravindan and B. Arora and K. Arunkarthik and T. Atmaram and Atmaram, {V. P.} and A. Avhad and S. Bagri and Balakrishnan, {N. S.} and Balamurugan and A. Banerjee and K. Banerjee and D. Bannerjee and V. Batra and Belgonkar, {R. N.} and S. Chakrabarty and A. Jain and R. Khanna and S. Kulkarni and N. Kumar and P. Kumar and M. Nayak and S. Nayak and R. Ranjan and Rao, {P. E.} and D. Saha and P. Sharma and V. Shenoy and R. Singh and Singh, {S. K.} and Tiwari, {S. P.} and S. Yadav",
year = "2015",
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Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients : Results from observational GLOBE Study. / behalf of GLOBE Investigators.

In: Indian Journal of Endocrinology and Metabolism, Vol. 19, No. 1, 01.01.2015, p. 129-135.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients

T2 - Results from observational GLOBE Study

AU - behalf of GLOBE Investigators

AU - Saboo, Banshi

AU - Reddy, Gundam Chandrasekhara

AU - Juneja, Subhashchander

AU - Kedia, Ashok Kumar

AU - Manjrekar, Pravin

AU - Rathod, Rahul

AU - Abdul, S.

AU - Acharya, P. N.

AU - Agarwal, A.

AU - Agarwal, A.

AU - Agarwal, N.

AU - Agarwal, R.

AU - Agarwala, B.

AU - Aghao, S.

AU - Ajit, V.

AU - Ali, H.

AU - Amichandwala, K.

AU - Anand, N. N.

AU - Anilkumar, R.

AU - Aravindan, G.

AU - Arora, B.

AU - Arunkarthik, K.

AU - Atmaram, T.

AU - Atmaram, V. P.

AU - Avhad, A.

AU - Bagri, S.

AU - Balakrishnan, N. S.

AU - Balamurugan,

AU - Banerjee, A.

AU - Banerjee, K.

AU - Bannerjee, D.

AU - Batra, V.

AU - Belgonkar, R. N.

AU - Chakrabarty, S.

AU - Jain, A.

AU - Khanna, R.

AU - Kulkarni, S.

AU - Kumar, N.

AU - Kumar, P.

AU - Nayak, M.

AU - Nayak, S.

AU - Ranjan, R.

AU - Rao, P. E.

AU - Saha, D.

AU - Sharma, P.

AU - Shenoy, V.

AU - Singh, R.

AU - Singh, S. K.

AU - Tiwari, S. P.

AU - Yadav, S.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

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JO - Indian Journal of Endocrinology and Metabolism

JF - Indian Journal of Endocrinology and Metabolism

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