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)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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new Delhi、インド
- Research Site
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Andhra Pradesh
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Nellure、Andhra Pradesh、インド
- Research Site
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Vishakhapatnam、Andhra Pradesh、インド
- Research Site
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Assam
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Guwahati、Assam、インド
- Research Site
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Delhi
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New Delhi、Delhi、インド
- Research Site
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Gujarat
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Ahmedabad、Gujarat、インド
- Research Site
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Rajkot、Gujarat、インド
- Research Site
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Vadodara、Gujarat、インド
- Research Site
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Haryana
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Karnal、Haryana、インド
- Research Site
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Yamunanagar、Haryana、インド
- Research Site
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Karnataka
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Bangalore、Karnataka、インド
- Research Site
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Kerala
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Trivandrum、Kerala、インド
- Research Site
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Kochi
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Cochin、Kochi、インド
- Research Site
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Madhya Pradesh
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Bhopal、Madhya Pradesh、インド
- Research Site
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Indore、Madhya Pradesh、インド
- Research Site
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Maharashtra
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Mumbai、Maharashtra、インド
- Research Site
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Pune、Maharashtra、インド
- Research Site
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Punjab
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Amritsar、Punjab、インド
- Research Site
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Chandigarh、Punjab、インド
- Research Site
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Ludhiana、Punjab、インド
- Research Site
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Rajasthan
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Jaipur、Rajasthan、インド
- Research Site
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Udaipur、Rajasthan、インド
- Research Site
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Tamiladu
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Madurai、Tamiladu、インド
- Research Site
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Tamilnadu
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Chennai、Tamilnadu、インド
- Research Site
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Telangana
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Hyderabad、Telangana、インド
- Research Site
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Hyderebad、Telangana、インド
- Research Site
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Uttar Pradesh
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Allahabad、Uttar Pradesh、インド
- Research Site
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Kanpur、Uttar Pradesh、インド
- Research Site
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Lucknow、Uttar Pradesh、インド
- Research Site
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Noida、Uttar Pradesh、インド
- Research Site
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West Bengal
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Kolkata、West Bengal、インド
- Research Site
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Medication usage in enrolled subjects
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reduction in HbA1C
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Dr Sanjay Kalra, MD, DM (Endocrinology)、Bharti Research Institute of Diabetes & Endocrinology, Karnal
- スタディディレクター：Dr Bhavesh P Kotak, FRCS, MS, D Orth、AstraZeneca Pharma India Ltd
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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