Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Medication usage in enrolled subjects | By Frequency of subjects taking different doses of saxagliptin and metformin | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in HbA1C | Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels | baseline and at 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Type 2 diabetes patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Sanjay Kalra, MD, DM (Endocrinology) | Bharti Research Institute of Diabetes & Endocrinology, Karnal | Study Chair |
| Dr Bhavesh P Kotak, FRCS, MS, D Orth | AstraZeneca Pharma India Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nellure | Andhra Pradesh | India | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31641633 | Derived | 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. |
| Label | URL |
|---|---|
| D1680R00019\_CSR\_Synopsis | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Research Site | 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided