Type 2 DiabetesONTARGET-INDIANCT02588859
Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients
An observational study of Type 2 Diabetes, run by AstraZeneca at 31 sites in India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,200 participants
- Where
- 31 sitesIndia
- Study dates
- 30 Oct 2015to 26 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes patients
Who may be able to join
- Patients willing to provide informed consent.
- Female or male patients aged 18 years or above.
- Patients with known case of Type 2 diabetes mellitus.
- Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
- Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.
Who cannot join
- Patients with Type 1 diabetes mellitus.
- Patients taking glucose lowering drugs apart from metformin or saxagliptin.
- Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
- Pregnant or lactating women.
- Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
India31 sites
Research Site
Ahmedabad, Gujarat
Research Site
Allahābād, Uttar Pradesh
Research Site
Amritsar, Punjab
Research Site
Bangalore, Karnataka
Research Site
Bhopal, Madhya Pradesh
Research Site
Chandigarh, Punjab
Research Site
Chennai, Tamil Nadu
Research Site
Guwahati, Assam
Research Site
Hyderabad, Telangana
Research Site
Hyderebad, Telangana
Research Site
Indore, Madhya Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Kanpur, Uttar Pradesh
Research Site
Karnāl, Haryana
Research Site
Kochi, Kochi
Research Site
Kolkata, West Bengal
Research Site
Lucknow, Uttar Pradesh
Research Site
Ludhiana, Punjab
Research Site
Madurai, Tamiladu
Research Site
Mumbai, Maharashtra
Research Site
Nellure, Andhra Pradesh
Research Site
New Delhi, National Capital Territory of Delhi
Research Site
New Delhi
Research Site
Noida, Uttar Pradesh
Research Site
Pune, Maharashtra
Research Site
Rajkot, Gujarat
Research Site
Trivandrum, Kerala
Research Site
Udaipur, Rajasthan
Research Site
Vadodara, Gujarat
Research Site
Visakhapatnam, Andhra Pradesh
Research Site
Yamuna Nagar, Haryana
About this study
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)
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- T2DM, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication usage in enrolled subjects
By Frequency of subjects taking different doses of saxagliptin and metformin
Measured: at 3 months
Secondary outcomes (1)
Reduction in HbA1C
Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels
Measured: baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start30 Oct 2015
- Primary completion26 Dec 2016
- Study completion26 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Sanjay Kalra, MD, DM (Endocrinology), Study chair, Bharti Research Institute of Diabetes & Endocrinology, KarnalDr Bhavesh P Kotak, FRCS, MS, D Orth, Study director, AstraZeneca Pharma India Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588859
- Sponsor's protocol ID
- D1680R00019
- Acronym
- ONTARGET-INDIA
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31641633
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02588859
- Acronym / sponsor ID
- ONTARGET-INDIA / D1680R00019
- Conditions
- Type 2 Diabetes
- Keywords
- T2DM, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 26 Dec 2016 (actual)
- Study completion
- 26 Dec 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes patients
Key inclusion criteria (5 listed)
- Patients willing to provide informed consent.
- Female or male patients aged 18 years or above.
- Patients with known case of Type 2 diabetes mellitus.
- Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
- Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.
Key exclusion criteria (5 listed)
- Patients with Type 1 diabetes mellitus.
- Patients taking glucose lowering drugs apart from metformin or saxagliptin.
- Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
- Pregnant or lactating women.
- Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication usage in enrolled subjects
Time frame: at 3 months
By Frequency of subjects taking different doses of saxagliptin and metformin
1 secondary outcome
Reduction in HbA1C
Time frame: baseline and at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 31641633Kalra 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.
- D1680R00019\_CSR\_SynopsisLink provided by the sponsor.
Related trials for Type 2 Diabetes
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sanjay Kalra, MD, DM (Endocrinology) study chair
Bharti Research Institute of Diabetes & Endocrinology, Karnal
Dr Bhavesh P Kotak, FRCS, MS, D Orth study director
AstraZeneca Pharma India Ltd
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca at 31 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication usage in enrolled subjects (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.