Type 2 Diabetes Mellitus Clinical Trial
— DONATEOfficial title:
Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
| Verified date | February 2022 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| 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 |
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