Clinical trial NCT03156985: Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
Official title: Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: within 6-months
Secondary outcomes:
Other outcomes:
measure: Absolute change in HbA1c
timeFrame: 6 months
measure: The proportion of patients achieving HbA1c less than 7.0%
timeFrame: 6 months
measure: The absolute change in fasting plasma glucose (FPG)
timeFrame: 6 months
measure: The absolute change in postprandial plasma glucose (PPG)
timeFrame: 6 months
measure: The absolute change in body weight
timeFrame: 6 months
measure: The absolute change in waist circumference
timeFrame: 6 months
measure: The absolute change in blood pressure
timeFrame: 6 months
measure: The incidence of interested adverse events
timeFrame: within 6 months
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Huainan
country: China
facility: Research Site
state: Anhui
city: Maanshan
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Lanzhou
country: China
facility: Research Site
state: Gan Su
city: Lanzhou
country: China
facility: Research Site
state: Gansu
city: Dongguan
country: China
facility: Research Site
state: Guangdong
city: Dongguan
country: China
facility: Research Site
state: Guangdong
city: Foshan
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Huizhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Yingde
country: China
facility: Research Site
state: Guangdong
city: Zhanjiang
country: China
facility: Research Site
state: Guangdong
city: Zhaoqing
country: China
facility: Research Site
state: Guangdong
city: Zhuhai
country: China
facility: Research Site
state: Guangdong
city: Zhuhai
country: China
facility: Research Site
state: Guangdong
city: Guilin
country: China
facility: Research Site
state: Guangxi
city: Guilin
country: China
facility: Research Site
state: Guangxi
city: Guiyang
country: China
facility: Research Site
state: Guizhou
city: Shijiazhuang
country: China
facility: Research Site
state: Hebi
city: Xingxiang
country: China
facility: Research Site
state: Henan
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Liuyang
country: China
facility: Research Site
state: Hunan
city: Hohhot
country: China
facility: Research Site
state: Inner Mongolia
city: Kunshan
country: China
facility: Research Site
state: Jiangsu
city: Kunshan
country: China
facility: Research Site
state: Jiangsu
city: Lianyungang
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nantong
country: China
facility: Research Site
state: Jiangsu
city: Qidong
country: China
facility: Research Site
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site
state: Jiangsu
city: Yancheng
country: China
facility: Research Site
state: Jiangsu
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Shengyang
country: China
facility: Research Site
state: Liaoning
city: Xining
country: China
facility: Research Site
state: Qinghai
city: Xian
country: China
facility: Research Site
state: Shaanxi
city: Xian
country: China
facility: Research Site
state: Shaanxi
city: Xian
country: China
facility: Research Site
state: Shaanxi
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Laizhou
country: China
facility: Research Site
state: Shandong
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Weifang
country: China
facility: Research Site
state: Shandong
city: Zibo
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Nanchong
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Urumqi
country: China
facility: Research Site
state: Xinjiang
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Ningbo
country: China
facility: Research Site
state: Zhejiang
city: Ningbo
country: China
facility: Research Site
state: Zhejiang
city: Ruian
country: China
facility: Research Site
state: Zhejiang
city: Wenling
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
References: