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

Type 2 Diabetes Mellitus Clinical Trial

— DONATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156985
• Other study ID #: D1690R00027
• Status: Completed
• Start date: August 16, 2017
• Est. completion date: January 27, 2021

Study information

• Verified date: February 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Changsha	Hunan
China	Research Site	Chongqing	Chongqing
China	Research Site	Chongqing	Chongqing
China	Research Site	Dalian	Liaoning
China	Research Site	Dongguan	Guangdong
China	Research Site	Dongguan	Guangdong
China	Research Site	Foshan	Guangdong
China	Research Site	Guangzhou	Guangdong
China	Research Site	Guangzhou	Guangdong
China	Research Site	Guangzhou	Guangdong
China	Research Site	Guangzhou	Guangdong
China	Research Site	Guilin	Guangxi
China	Research Site	Guilin	Guangxi
China	Research Site	Guiyang	Guizhou
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Hefei	Anhui
China	Research Site	Hohhot	Inner Mongolia
China	Research Site	Huainan	Anhui
China	Research Site	Huizhou	Guangdong
China	Research Site	Jinan	Shandong
China	Research Site	Kunming	Yunnan
China	Research Site	Kunshan	Jiangsu
China	Research Site	Kunshan	Jiangsu
China	Research Site	Laizhou	Shandong
China	Research Site	Lanzhou	Gan Su
China	Research Site	Lanzhou	Gansu
China	Research Site	Lianyungang	Jiangsu
China	Research Site	Liuyang	Hunan
China	Research Site	Maanshan	Anhui
China	Research Site	Nanchong	Sichuan
China	Research Site	Nanjing	Jiangsu
China	Research Site	Nanjing	Jiangsu
China	Research Site	Nantong	Jiangsu
China	Research Site	Ningbo	Zhejiang
China	Research Site	Ningbo	Zhejiang
China	Research Site	Qidong	Jiangsu
China	Research Site	Qingdao	Shandong
China	Research Site	Ruian	Zhejiang
China	Research Site	Shanghai	Shanghai
China	Research Site	Shengyang	Liaoning
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shijiazhuang	Hebi
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin	Tianjin
China	Research Site	Tianjin	Tianjin
China	Research Site	Tianjin	Tianjin
China	Research Site	Tianjin	Tianjin
China	Research Site	Urumqi	Xinjiang
China	Research Site	Weifang	Shandong
China	Research Site	Wenling	Zhejiang
China	Research Site	Wenzhou	Zhejiang
China	Research Site	Wuhan	Hubei
China	Research Site	Wuhan	Hubei
China	Research Site	Xian	Shaanxi
China	Research Site	Xian	Shaanxi
China	Research Site	Xian	Shaanxi
China	Research Site	Xingxiang	Henan
China	Research Site	Xining	Qinghai
China	Research Site	Xuzhou	Jiangsu
China	Research Site	Xuzhou	Jiangsu
China	Research Site	Yancheng	Jiangsu
China	Research Site	Yingde	Guangdong
China	Research Site	Zhanjiang	Guangdong
China	Research Site	Zhaoqing	Guangdong
China	Research Site	Zhengzhou	Henan
China	Research Site	Zhuhai	Guangdong
China	Research Site	Zhuhai	Guangdong
China	Research Site	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute change in HbA1c	Absolute change in HbA1c after the treatment with dapagliflozin	6 months
Other	The proportion of patients achieving HbA1c less than 7.0%	The proportion of patients achieving HbA1c less than 7.0% after treatment with dapagliflozin that will be presented by percentage.	6 months
Other	The absolute change in fasting plasma glucose (FPG)	The absolute change in FPG after treatment with dapagliflozin	6 months
Other	The absolute change in postprandial plasma glucose (PPG)	The absolute change in PPG after treatment with dapagliflozin	6 months
Other	The absolute change in body weight	The absolute change in body weight after treatment with dapagliflozin.	6 months
Other	The absolute change in waist circumference	The absolute change in waist circumference after treatment with dapagliflozin.	6 months
Other	The absolute change in blood pressure	The absolute change in blood pressure after treatment with dapagliflozin.	6 months
Other	The incidence of interested adverse events	The incidence of interested adverse events, including volume depletion, abnormal of blood electrolytes, polyuria, renal impairment, diabetic ketoacidosis, hepatic impairment, and hematuria, will be presented by number and percentage.	within 6 months
Primary	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

External Links

•   Redacted CSR synopsis