Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients (ONTARGET-INDIA)
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)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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new Delhi, 인도
- Research Site
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Andhra Pradesh
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Nellure, Andhra Pradesh, 인도
- Research Site
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Vishakhapatnam, Andhra Pradesh, 인도
- Research Site
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Assam
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Guwahati, Assam, 인도
- Research Site
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Delhi
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New Delhi, Delhi, 인도
- Research Site
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Gujarat
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Ahmedabad, Gujarat, 인도
- Research Site
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Rajkot, Gujarat, 인도
- Research Site
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Vadodara, Gujarat, 인도
- Research Site
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Haryana
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Karnal, Haryana, 인도
- Research Site
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Yamunanagar, Haryana, 인도
- Research Site
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Karnataka
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Bangalore, Karnataka, 인도
- Research Site
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Kerala
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Trivandrum, Kerala, 인도
- Research Site
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Kochi
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Cochin, Kochi, 인도
- Research Site
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Madhya Pradesh
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Bhopal, Madhya Pradesh, 인도
- Research Site
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Indore, Madhya Pradesh, 인도
- Research Site
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Maharashtra
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Mumbai, Maharashtra, 인도
- Research Site
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Pune, Maharashtra, 인도
- Research Site
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Punjab
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Amritsar, Punjab, 인도
- Research Site
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Chandigarh, Punjab, 인도
- Research Site
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Ludhiana, Punjab, 인도
- Research Site
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Rajasthan
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Jaipur, Rajasthan, 인도
- Research Site
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Udaipur, Rajasthan, 인도
- Research Site
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Tamiladu
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Madurai, Tamiladu, 인도
- Research Site
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Tamilnadu
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Chennai, Tamilnadu, 인도
- Research Site
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Telangana
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Hyderabad, Telangana, 인도
- Research Site
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Hyderebad, Telangana, 인도
- Research Site
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Uttar Pradesh
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Allahabad, Uttar Pradesh, 인도
- Research Site
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Kanpur, Uttar Pradesh, 인도
- Research Site
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Lucknow, Uttar Pradesh, 인도
- Research Site
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Noida, Uttar Pradesh, 인도
- Research Site
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West Bengal
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Kolkata, West Bengal, 인도
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Medication usage in enrolled subjects
기간: at 3 months
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By Frequency of subjects taking different doses of saxagliptin and metformin
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at 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction in HbA1C
기간: baseline and at 3 months
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Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels
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baseline and at 3 months
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Dr Sanjay Kalra, MD, DM (Endocrinology), Bharti Research Institute of Diabetes & Endocrinology, Karnal
- 연구 책임자: Dr Bhavesh P Kotak, FRCS, MS, D Orth, AstraZeneca Pharma India Ltd
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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