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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Research Site
Hefei, Anhui, China
Research Site
Huainan, Anhui, China
Research Site
Maanshan, Anhui, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
...and 73 more locations
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.
Time frame: within 6-months
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