NCT03084965

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,987

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

March 15, 2017

Last Update Submit

February 25, 2019

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

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

    6 months

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 Diabetes Mellitus patients on Dapagliflozin Therapy in Taiwan

You may qualify if:

  • Outpatient equal to or more than 20 years of age.
  • 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.
  • Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy.
  • Will provide completed and signed written informed consents.

You may not qualify if:

  • Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline.
  • Subjects with Type 1 diabetes.
  • Treatment with other investigational drugs concurrently during the retrospective data collection period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Changhua, Taiwan

Location

Research Site

Chiayi City, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

New Taipei City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan District, Taiwan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 21, 2017

Study Start

May 12, 2017

Primary Completion

March 2, 2018

Study Completion

March 2, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

TW(8)