Type 2 Diabetes MellitusDONATENCT03156985

Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China

An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 83 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
How many people: 3,000 participants
Where: 83 sitesChina
Study dates: 16 Aug 2017to 27 Jan 2021
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: 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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

83 sites in 1 country.

City, postcode or hospital

83 sites in 1 country

China83 sites

Research Site
Beijing, Beijing Municipality, 100028
Research Site
Beijing, Beijing Municipality, 100043
Research Site
Beijing, Beijing Municipality, 100054
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Beijing, Beijing Municipality, 100062
Research Site
Beijing, Beijing Municipality, 100076
Research Site
Beijing, Beijing Municipality, 100078
Research Site
Beijing, Beijing Municipality, 100080
Research Site
Beijing, Beijing Municipality, 100095
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Beijing, Beijing Municipality, 100123
Research Site
Beijing, Beijing Municipality, 100730
Research Site
Beijing, Beijing Municipality, 102500
Research Site
Changsha, Hunan, 410006
Research Site
Changsha, Hunan, 410200
Research Site
Chongqing, Chongqing Municipality, 400014
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Chongqing, Chongqing Municipality, 408000
Research Site
Dalian, Liaoning, 116003
Research Site
Dongguan, Guangdong, 523073
Research Site
Dongguan, Guangdong, 523413
Research Site
Foshan, Guangdong, 528251
Research Site
Guangzhou, Guangdong, 510075
Research Site
Guangzhou, Guangdong, 510150
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Guangzhou, Guangdong, 510811
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Guangzhou, Guangdong, 510900
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Guankou, Hunan, 410300
Research Site
Guilin, Guangxi, 541002
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Guilin, Guangxi, 541003
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Guiyang, Guizhou, 550005
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Hangzhou, Zhejiang, 310006
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Hefei, Anhui, 230011
Research Site
Hohhot, Inner Mongolia, 0
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Huainan, Anhui, 232001
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Huizhou, Guangdong, 516002
Research Site
Jinan, Shandong, 250000
Research Site
Kunming, Yunnan, 650204
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Kunshan, Jiangsu, 0
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Kunshan, Jiangsu, 215300
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Laizhou, Shandong, 261400
Research Site
Lanzhou, Gansu, 730000
Research Site
Lanzhou, Gansu, 730030
Research Site
Lianyungang, Jiangsu, 222023
Research Site
Maanshan, Anhui, 243000
Research Site
Nanchong, Sichuan, 637000
Research Site
Nanjing, Jiangsu, 210000
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Nanjing, Jiangsu, 211100
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Nantong, Jiangsu, 226200
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Ningbo, Zhejiang, 315010
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Ningbo, Zhejiang, 315020
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Qidong, Jiangsu, 226200
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Qingdao, Shandong, 266000
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Ruian, Zhejiang, 325200
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Shanghai, Shanghai Municipality, 200120
Research Site
Shengyang, Liaoning, 110000
Research Site
Shenzhen, Guangdong, 518005
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Shenzhen, Guangdong, 518052
Research Site
Shenzhen, Guangdong, 518101
Research Site
Shenzhen, Guangdong, 518119
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Shijiazhuang, Hebi, 458000
Research Site
Taiyuan, Shanxi, 0
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Tianjin, Tianjin Municipality, 0
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Tianjin, Tianjin Municipality, 300052
Research Site
Tianjin, Tianjin Municipality, 300140
Research Site
Tianjin, Tianjin Municipality, 300450
Research Site
Ürümqi, Xinjiang, 830000
Research Site
Weifang, Shandong, 261000
Research Site
Wenling, Zhejiang, 317500
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Wenzhou, Zhejiang, 325000
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Wuhan, Hubei, 430015
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Wuhan, Hubei, 430022
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Xi'an, Shaanxi, 710000
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Xi'an, Shaanxi, 710054
Research Site
Xi'an, Shaanxi, 710100
Research Site
Xingxiang, Henan, 453000
Research Site
Xining, Qinghai, 810000
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Xuzhou, Jiangsu, 221005
Research Site
Xuzhou, Jiangsu, 221009
Research Site
Yancheng, Jiangsu, 224000
Research Site
Yingcheng, Guangdong, 513061
Research Site
Zhanjiang, Guangdong, 524045
Research Site
Zhaoqing, Guangdong, 526040
Research Site
Zhengzhou, Henan, 450014
Research Site
Zhuhai, Guangdong, 519001
Research Site
Zhuhai, Guangdong, 519099
Research Site
Zibo, Shandong, 255020

Other trials in China

About this study

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.

Conditions: Type 2 Diabetes Mellitus
Medical subject headings: Diabetes Mellitus, Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: within 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 201727 Jan 2021

First posted17 May 2017
Study start16 Aug 2017
Primary completion27 Jan 2021
Study completion27 Jan 2021

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 Diabetes MellitusStudies 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: Cohort
Time perspective: Prospective
Enrolment: 3,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03156985
Sponsor's protocol ID: D1690R00027
Acronym: DONATE
Status last verified: Feb 2022
First submitted: 16 May 2017
Last updated: 24 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 37316847

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
ClinicalTrials.gov ID: NCT03156985
Acronym / sponsor ID: DONATE / D1690R00027
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 16 Aug 2017 (actual)
Primary completion: 27 Jan 2021 (actual)
Study completion: 27 Jan 2021 (actual)
First posted: 17 May 2017 (actual)
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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

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

Incidence of adverse events
Time frame: within 6-months
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.

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 24 Feb 2022.
Derived from this study: PubMed 37316847Guo 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.
Redacted CSR synopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Type 2 Diabetes Mellitus

RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Diabetes Mellitus, Type 2, Cancer
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
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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.

The record lists no contact. Use the official record to reach the sponsor.

83 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 Mellitus, run by AstraZeneca at 83 sites in China.

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 4 inclusion and 3 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 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in China. 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?

Incidence of adverse events (time frame: within 6-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 NCT03156985, 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 24 Feb 2022; AzTrials last refreshed its copy on 30 Oct 2026.