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Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study (ONTARGET-INDIA).

ABSTRACT: 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 safety event identified is an increased risk of hospitalisation in heart failure patients. This study is also registered on Clinicaltrials.gov (NCT02588859).

SUBMITTER: Kalra S

PROVIDER: S-EPMC6683677 | biostudies-literature | 2019 May-Jun

REPOSITORIES: biostudies-literature

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Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study (ONTARGET-INDIA).

Kalra Sanjay S Bajaj Sarita S Unnikrishnan A G AG Baruah Manash P MP Sahay Rakesh R Hardik V V Kumar Amit A

Indian journal of endocrinology and metabolism 20190501 3

<h4>Introduction</h4>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.<h4>Methodology</h4>It was a multicenter, prospective, non-interventional and observational study planned to enrol ...[more]

PMID: 31641633

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Project description:ObjectiveThe correct path after finishing residency in cardiac surgery (CS) has been unclear to most of the young cardiac surgeons. Pursuing a fellowship abroad is by far the most preferred option for many residents after residency. We report the results of the first nationwide survey on the experience of Indian cardiac surgeons who have pursued a fellowship abroad.MethodsA 10-question Web-based survey was distributed in March, 2018, to all cardiac surgeons in India who have done at least 1 year of fellowship or registrarship in CS abroad. A reminder was sent after 1 month. All responses were verified for genuineness and entirety. A significant 55 responses qualified for survey analysis.ResultsFifty-five surgeons with a mean experience of 8.1 years after residency and at least 1 year of international training responded to the survey. Australia and New Zealand were the most common countries opted for post-residency training and a majority did a 2-year international fellowship. Most of them were fairly satisfied with protocol learning (4.1/5), research work (3.3/5) and financial support (3.7/5) but not with the surgical hands-on experience (2.9/5). The greatest challenge after the fellowship was to establish an independent practice and get patient referrals. Forty per cent of the surgeons felt that Indian post-residency training could be comparable to international fellowships if the centre is chosen wisely. A few (16%) of them even believed that Indian post-residency training is better than international fellowships.ConclusionsInternational fellowships have their own merits and demerits and are to be chosen wisely. In the present situation, Indian post-residency training for basic surgical work is comparable to that of overseas. However, international exposure is recommended for learning advances in cardiac surgical subspecialities like minimally invasive cardiac surgery (MICS), robotic CS, aortic and endovascular techniques and heart failure surgeries.

Dataset Information

Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study (ONTARGET-INDIA).

Publications

Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study (ONTARGET-INDIA).

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