Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT02588859
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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)
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONTARGET-INDIA
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: