Study identifier:D1680R00019
ClinicalTrials.gov identifier:NCT02588859
EudraCT identifier:N/A
CTIS identifier:N/A
A Non-Interventional, multicentre, prospective, observational Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Patients. (ONTARGET-India)
Type 2 Diabetes
N/A
No
-
All
1200
Observational
N/A
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Dec 2017 by AstraZeneca
AstraZeneca
-
This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently prescribed saxagliptin as an add-on to metformin.
This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently (i.e. within past 15 days) prescribed saxagliptin as an add-on to metformin. 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.
Location
Location
Karnal, Haryana, India
Location
Lucknow, Uttar Pradesh, India
Location
Kanpur, Uttar Pradesh, India
Location
Chandigarh, Punjab, India
Location
Allahabad, Uttar Pradesh, India
Location
Amritsar, Punjab, India
Location
Trivandrum, Kerala, India
Location
Nellure, Andhra Pradesh, India
Arms | Assigned Interventions |
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