Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
DONATE
1 other identifier
observational
3,000
1 country
83
Brief Summary
DONATE study is a multi-center, prospective cohort, single arm, observational study to be performed in 3000 Chinese type 2 diabetes mellitus (T2DM) patients recruited from 100 tier 2 or 3 hospitals, China.It is a drug intense monitoring study required by China Food and Drug Administration (CFDA) to assess the newly approved drug in at least 3000 patients within the first five years after commercial launch. The primary objective is to demonstrate the safety of dapagliflozin by assessment of the incidence of adverse events and serious adverse events during 6-month follow up in Chinese patients with T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2021
CompletedFebruary 24, 2022
February 1, 2022
3.5 years
May 16, 2017
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
The adverse event will be collected and coded using latest version of MedDra. The incidence of adverse events will be presented using the number and percentages by System Organ Class and Preferred Term.
within 6-months
Other Outcomes (8)
Absolute change in HbA1c
6 months
The proportion of patients achieving HbA1c less than 7.0%
6 months
The absolute change in fasting plasma glucose (FPG)
6 months
- +5 more other outcomes
Eligibility Criteria
T2DM diagnosed by physicians according to 2013 Chinese Guideline for Diabetes and had been initiated the therapy of dapagliflozin by a physician (any licensed physician is qualified) and had taken at least one dose of dapagliflozin.
You may qualify if:
- Provision of subject informed consent prior to any study specific procedures.
- Chinese, Female or male.
- T2DM diagnosed by physicians according to 2013 Chinese Guideline for Diabetes, ie. 1) Patients with typical syndrome and with a FPG ≥ 7.0mmol/L and/or random plasma glucose ≥ 11.1mmol/L; and/or, 2) patients without typical syndrome and with repeated FPG ≥ 7.0mmol/L and/or 2 hour post challenged plasma glucose ≥ 11.1mmol/L.
- Subjects who already took at least one dose of dapagliflozin, which is prescribed by physicians based on their clinical practice. The prescription of dapagliflozin is separated from the decision to be included in the current study or not.
You may not qualify if:
- Being unable to comply with study-specified procedures.
- Participating in any other clinical trial currently or during the last 3 months.
- Previous enrolment in the present study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (83)
Research Site
Hefei, Anhui, 230011, China
Research Site
Huainan, Anhui, 232001, China
Research Site
Maanshan, Anhui, 243000, China
Research Site
Beijing, Beijing Municipality, 100028, China
Research Site
Beijing, Beijing Municipality, 100043, China
Research Site
Beijing, Beijing Municipality, 100054, China
Research Site
Beijing, Beijing Municipality, 100062, China
Research Site
Beijing, Beijing Municipality, 100076, China
Research Site
Beijing, Beijing Municipality, 100078, China
Research Site
Beijing, Beijing Municipality, 100080, China
Research Site
Beijing, Beijing Municipality, 100095, China
Research Site
Beijing, Beijing Municipality, 100123, China
Research Site
Beijing, Beijing Municipality, 100730, China
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Beijing, Beijing Municipality, 102500, China
Research Site
Chongqing, Chongqing Municipality, 400014, China
Research Site
Chongqing, Chongqing Municipality, 408000, China
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Lanzhou, Gansu, 730000, China
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Lanzhou, Gansu, 730030, China
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Dongguan, Guangdong, 523073, China
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Dongguan, Guangdong, 523413, China
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Foshan, Guangdong, 528251, China
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Guangzhou, Guangdong, 510075, China
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Guangzhou, Guangdong, 510150, China
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Guangzhou, Guangdong, 510811, China
Research Site
Guangzhou, Guangdong, 510900, China
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Huizhou, Guangdong, 516002, China
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Shenzhen, Guangdong, 518005, China
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Shenzhen, Guangdong, 518052, China
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Shenzhen, Guangdong, 518101, China
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Shenzhen, Guangdong, 518119, China
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Yingcheng, Guangdong, 513061, China
Research Site
Zhanjiang, Guangdong, 524045, China
Research Site
Zhaoqing, Guangdong, 526040, China
Research Site
Zhuhai, Guangdong, 519001, China
Research Site
Zhuhai, Guangdong, 519099, China
Research Site
Guilin, Guangxi, 541002, China
Research Site
Guilin, Guangxi, 541003, China
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Guiyang, Guizhou, 550005, China
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Shijiazhuang, Hebi, 458000, China
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Xingxiang, Henan, 453000, China
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Zhengzhou, Henan, 450014, China
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Wuhan, Hubei, 430015, China
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Wuhan, Hubei, 430022, China
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Changsha, Hunan, 410006, China
Research Site
Changsha, Hunan, 410200, China
Research Site
Guankou, Hunan, 410300, China
Research Site
Hohhot, Inner Mongolia, 0, China
Research Site
Kunshan, Jiangsu, 0, China
Research Site
Kunshan, Jiangsu, 215300, China
Research Site
Lianyungang, Jiangsu, 222023, China
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Nanjing, Jiangsu, 210000, China
Research Site
Nanjing, Jiangsu, 211100, China
Research Site
Nantong, Jiangsu, 226200, China
Research Site
Qidong, Jiangsu, 226200, China
Research Site
Xuzhou, Jiangsu, 221005, China
Research Site
Xuzhou, Jiangsu, 221009, China
Research Site
Yancheng, Jiangsu, 224000, China
Research Site
Dalian, Liaoning, 116003, China
Research Site
Shengyang, Liaoning, 110000, China
Research Site
Xining, Qinghai, 810000, China
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Xi'an, Shaanxi, 710000, China
Research Site
Xi'an, Shaanxi, 710054, China
Research Site
Xi'an, Shaanxi, 710100, China
Research Site
Jinan, Shandong, 250000, China
Research Site
Laizhou, Shandong, 261400, China
Research Site
Qingdao, Shandong, 266000, China
Research Site
Weifang, Shandong, 261000, China
Research Site
Zibo, Shandong, 255020, China
Research Site
Shanghai, Shanghai Municipality, 200120, China
Research Site
Taiyuan, Shanxi, 0, China
Research Site
Nanchong, Sichuan, 637000, China
Research Site
Tianjin, Tianjin Municipality, 0, China
Research Site
Tianjin, Tianjin Municipality, 300052, China
Research Site
Tianjin, Tianjin Municipality, 300140, China
Research Site
Tianjin, Tianjin Municipality, 300450, China
Research Site
Ürümqi, Xinjiang, 830000, China
Research Site
Kunming, Yunnan, 650204, China
Research Site
Hangzhou, Zhejiang, 310006, China
Research Site
Ningbo, Zhejiang, 315010, China
Research Site
Ningbo, Zhejiang, 315020, China
Research Site
Ruian, Zhejiang, 325200, China
Research Site
Wenling, Zhejiang, 317500, China
Research Site
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
Guo L, Wang J, Li L, Yuan L, Chen S, Wang H, Li T, Qi L, Yang H. A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE). BMC Med. 2023 Jun 14;21(1):212. doi: 10.1186/s12916-023-02906-7.
PMID: 37316847DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 17, 2017
Study Start
August 16, 2017
Primary Completion
January 27, 2021
Study Completion
January 27, 2021
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.