Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients
NCT ID: NCT02588859
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2015-10-30
2016-12-26
Brief Summary
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Detailed Description
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The Investigator/designee would get signed informed consent from potential subjects of the study. The patients who meet all inclusion and none of the exclusion criteria will be enrolled in the study. These patients will then be assigned a patient identification number for the study. The Investigator/designee will collect the information as per the study schedule. This will be considered as Visit 1 of the patients. The patients will be managed as per the routine clinical practice of the physician for their condition and this study will neither interfere/advise the Investigators/designee for any drug/medication to be prescribed to the patients nor prescribe any intervention to them.The enrolled patients would then be asked to visit their respective study sites after 3 months ( +7 days) for the Visit-2 of study.
Around 50 study centers throughout India will be selected with a goal of enrolling up to 1500 patients (approximately 30 subjects each per site). The study will be initiated after obtaining written approval of Independent/Institutional Ethics Committee and written Informed consent of the patient.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Female or male patients aged 18 years or above.
3. Patients with known case of Type 2 diabetes mellitus.
4. Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
5. Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.
Exclusion Criteria
2. Patients taking glucose lowering drugs apart from metformin or saxagliptin.
3. Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
4. Pregnant or lactating women.
5. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Sanjay Kalra, MD, DM (Endocrinology)
Role: STUDY_CHAIR
Bharti Research Institute of Diabetes & Endocrinology, Karnal
Dr Bhavesh P Kotak, FRCS, MS, D Orth
Role: STUDY_DIRECTOR
AstraZeneca Pharma India Ltd
Locations
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Research Site
Nellure, Andhra Pradesh, India
Research Site
Visakhapatnam, Andhra Pradesh, India
Research Site
Guwahati, Assam, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Rajkot, Gujarat, India
Research Site
Vadodara, Gujarat, India
Research Site
Karnāl, Haryana, India
Research Site
Yamuna Nagar, Haryana, India
Research Site
Bangalore, Karnataka, India
Research Site
Trivandrum, Kerala, India
Research Site
Kochi, Kochi, India
Research Site
Bhopal, Madhya Pradesh, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Mumbai, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
New Delhi, National Capital Territory of Delhi, India
Research Site
Amritsar, Punjab, India
Research Site
Chandigarh, Punjab, India
Research Site
Ludhiana, Punjab, India
Research Site
Jaipur, Rajasthan, India
Research Site
Udaipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Madurai, Tamiladu, India
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Hyderabad, Telangana, India
Research Site
Hyderebad, Telangana, India
Research Site
Allahābād, Uttar Pradesh, India
Research Site
Kanpur, Uttar Pradesh, India
Research Site
Lucknow, Uttar Pradesh, India
Research Site
Noida, Uttar Pradesh, India
Research Site
Kolkata, West Bengal, India
Research Site
New Delhi, , India
Countries
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References
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Kalra S, Bajaj S, Unnikrishnan AG, Baruah MP, Sahay R, Hardik V, Kumar A. Therapeutic Experience of Saxagliptin as First Add-on after Metformin in Indian Type 2 Diabetes Patients: A Non-interventional, Prospective, Observational Study (ONTARGET-INDIA). Indian J Endocrinol Metab. 2019 May-Jun;23(3):312-317. doi: 10.4103/ijem.IJEM_56_19.
Related Links
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Other Identifiers
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D1680R00019
Identifier Type: -
Identifier Source: org_study_id