Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients

Type 2 Diabetes Clinical Trial

— ONTARGET-INDIA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588859
• Other study ID #: D1680R00019
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: December 18, 2017
• Start date: October 30, 2015
• Est. completion date: December 26, 2016

Study information

• Verified date: December 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 26, 2016
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Allahabad	Uttar Pradesh
India	Research Site	Amritsar	Punjab
India	Research Site	Bangalore	Karnataka
India	Research Site	Bhopal	Madhya Pradesh
India	Research Site	Chandigarh	Punjab
India	Research Site	Chennai	Tamilnadu
India	Research Site	Cochin	Kochi
India	Research Site	Guwahati	Assam
India	Research Site	Hyderabad	Telangana
India	Research Site	Hyderebad	Telangana
India	Research Site	Indore	Madhya Pradesh
India	Research Site	Jaipur	Rajasthan
India	Research Site	Kanpur	Uttar Pradesh
India	Research Site	Karnal	Haryana
India	Research Site	Kolkata	West Bengal
India	Research Site	Lucknow	Uttar Pradesh
India	Research Site	Ludhiana	Punjab
India	Research Site	Madurai	Tamiladu
India	Research Site	Mumbai	Maharashtra
India	Research Site	Nellure	Andhra Pradesh
India	Research Site	New Delhi	Delhi
India	Research Site	new Delhi
India	Research Site	Noida	Uttar Pradesh
India	Research Site	Pune	Maharashtra
India	Research Site	Rajkot	Gujarat
India	Research Site	Trivandrum	Kerala
India	Research Site	Udaipur	Rajasthan
India	Research Site	Vadodara	Gujarat
India	Research Site	Vishakhapatnam	Andhra Pradesh
India	Research Site	Yamunanagar	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication usage in enrolled subjects	By Frequency of subjects taking different doses of saxagliptin and metformin	at 3 months
Secondary	Reduction in HbA1C	Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels	baseline and at 3 months

External Links

•   D1680R00019_CSR_Synopsis