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

December 18, 2017 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication usage in enrolled subjects
Time Frame: at 3 months
By Frequency of subjects taking different doses of saxagliptin and metformin
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in HbA1C
Time Frame: baseline and at 3 months
Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels
baseline and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Dr Sanjay Kalra, MD, DM (Endocrinology), Bharti Research Institute of Diabetes & Endocrinology, Karnal
  • Study Director: Dr Bhavesh P Kotak, FRCS, MS, D Orth, AstraZeneca Pharma India Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2015

Primary Completion (Actual)

December 26, 2016

Study Completion (Actual)

December 26, 2016

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680R00019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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