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NCT Number: NCT03156985

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Other outcomes

  1. Absolute change in HbA1c

    Time frame: 6 months

    Absolute change in HbA1c after the treatment with dapagliflozin

  2. The proportion of patients achieving HbA1c less than 7.0%

    Time frame: 6 months

    The proportion of patients achieving HbA1c less than 7.0% after treatment with dapagliflozin that will be presented by percentage.

  3. The absolute change in fasting plasma glucose (FPG)

    Time frame: 6 months

    The absolute change in FPG after treatment with dapagliflozin

  4. The absolute change in postprandial plasma glucose (PPG)

    Time frame: 6 months

    The absolute change in PPG after treatment with dapagliflozin

  5. The absolute change in body weight

    Time frame: 6 months

    The absolute change in body weight after treatment with dapagliflozin.

  6. The absolute change in waist circumference

    Time frame: 6 months

    The absolute change in waist circumference after treatment with dapagliflozin.

  7. The absolute change in blood pressure

    Time frame: 6 months

    The absolute change in blood pressure after treatment with dapagliflozin.

  8. The incidence of interested adverse events

    Time frame: within 6 months

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: DONATE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 17, 2017
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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