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ORIGINAL ARTICLE
Year : 2019  |  Volume : 23  |  Issue : 3  |  Page : 312-317

Therapeutic experience of saxagliptin as first add-on after metformin in Indian type 2 diabetes patients: A non-interventional, prospective, observational study (ONTARGET-INDIA)


1 Department of Endocrinology, Bharti Research Institute of Diabetes and Endocrinology, Karnal, Haryana, India
2 Department of Medicine, Moti Lal Nehru Medical College, Allahabad, Uttar Pradesh, India
3 Department of Clinical Diabetology and Endocrinology, Chellaram Diabetes Institute, Pune, Maharashtra, India
4 Department of Endocrinology, Excel Center, Maya Ville, Barthakur Mill Road, Ulubari, Guwahati, Assam, India
5 Department of Endocrinology, Osmania General Hospital, Hyderabad, Telangana, India
6 Department of Medical Affairs, AstraZeneca Pharma India Ltd, Bengaluru, Karnataka, India

Correspondence Address:
Sanjay Kalra
Departments of Endocrinologist, Bharti Research Institute of Diabetes and Endocrinology, Karnal - 132 001, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijem.IJEM_56_19

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Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitus (T2DM) patients but the data available in existing clinical trial programmes on DPP4 inhibitors include limited number of patients from India. Hence, this study attempted to understand usage, efficacy and safety of saxagliptin as first add-on after metformin in Indians with T2DM. Methodology: It was a multicenter, prospective, non-interventional and observational study planned to enrol T2DM patients who were inadequately controlled with metformin alone and had been recently (i.e., within past 15 days) prescribed saxagliptin as an add-on to metformin. Type 1 diabetes mellitus, use of glucose lowering drugs apart from metformin or saxagliptin, pregnancy, lactation, and medical condition, which could interfere with safe completion of the study were excluded. Results: A total of 1109 participants (658 men and 451 women) with mean ± SD age of 51.17 ± 11.85 years were enrolled from 50 centres throughout India. Significant reduction was observed in mean ± SD change of HbA1c as − 0.86% ± 1.76 from baseline to after 3 months of therapy (P < 0.0001). The quality of life assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire was reported to be “good” or “neither good nor bad” by majority of the participants at baseline and after 3 months of treatment. A total of 15 adverse events (AEs) were reported in the study, however, no serious adverse event (SAE) occurred during the study. All AEs were of mild intensity and did not require any intervention. Conclusion: Overall, saxagliptin in combination with metformin was generally well-tolerated in Indian T2DM patients and new or unexpected safety events were not identified. This study is also registered on Clinicaltrials.gov (NCT02588859).


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