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

Completed

• Conditions: Type II Diabetes Mellitus

• Registration Number: NCT03084965
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-21
• Study Start: 2017-05-12
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1987

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	To assess the change from baseline (time to initiate dapagliflozin\*) in HbA1c at 6 months

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taoyuan, Taiwan