Clinical trial NCT02588859: Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: T2DM, Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients

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.

Eligibility criteria: Inclusion Criteria:

1. Patients willing to provide informed consent.
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:

1. Patients with Type 1 diabetes mellitus.
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.

Primary outcomes:
measure: Medication usage in enrolled subjects
timeFrame: at 3 months
Secondary outcomes:
measure: Reduction in HbA1C
timeFrame: baseline and at 3 months
Other outcomes:
Locations:
city: Nellure
country: India
facility: Research Site
state: Andhra Pradesh
city: Vishakhapatnam
country: India
facility: Research Site
state: Andhra Pradesh
city: Guwahati
country: India
facility: Research Site
state: Assam
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Rajkot
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Karnal
country: India
facility: Research Site
state: Haryana
city: Yamunanagar
country: India
facility: Research Site
state: Haryana
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Cochin
country: India
facility: Research Site
state: Kochi
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Amritsar
country: India
facility: Research Site
state: Punjab
city: Chandigarh
country: India
facility: Research Site
state: Punjab
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Udaipur
country: India
facility: Research Site
state: Rajasthan
city: Madurai
country: India
facility: Research Site
state: Tamiladu
city: Chennai
country: India
facility: Research Site
state: Tamilnadu
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Hyderebad
country: India
facility: Research Site
state: Telangana
city: Allahabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Kanpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: new Delhi
country: India
facility: Research Site
Study officials:
affiliation: Bharti Research Institute of Diabetes & Endocrinology, Karnal
name: Dr Sanjay Kalra, MD, DM (Endocrinology)
role: STUDY_CHAIR
affiliation: AstraZeneca Pharma India Ltd
name: Dr Bhavesh P Kotak, FRCS, MS, D Orth
role: STUDY_DIRECTOR
References:
citation: 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.