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NCT03084965 Clinical Trial

Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Type II Diabetes Mellitus Clinical Trial

Official title:
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03084965
Other study ID # D1690R00022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2017
Est. completion date March 2, 2018

Study information
Verified date February 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan.

Recruitment information / eligibility
Status Completed
Enrollment 1987
Est. completion date March 2, 2018
Est. primary completion date March 2, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria:

1. Outpatient equal to or more than 20 years of age.

2. T2DM patient initiated dapagliflozin after May 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. Or initiating dapagliflozin as adjunctive therapy for T2DM subjects treated with insulin.

3. Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy.

4. Will provide completed and signed written informed consents.

Exclusion Criteria:

1. Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline.

2. Subjects with Type 1 diabetes.

3. Treatment with other investigational drugs concurrently during the retrospective data collection period.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Research Site Changhua
Taiwan Research Site Chiayi
Taiwan Research Site Kaohsiung
Taiwan Research Site New Taipei
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c To assess the change from baseline (time to initiate dapagliflozin*) in HbA1c at 6 months 6 months
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