NCT02252224

Brief Summary

This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,123

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

September 23, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

September 26, 2014

Last Update Submit

March 13, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • The number and incidence rate of adverse events and serious adverse event including unexpected adverse drug reactions

    All patients should be evaluated if they received at least one dose of the study medication. Safety will be evaluated through: • Incidence of serious adverse events • Incidence of unexpected adverse drug reactions • Identification of AE profile in usual practice • Report of AE in routine office visit or through phone or e-mail follow up • Incidence of nonserious adverse events All AEs that occurred on the surveillance drug treatment or within 3 days after the end of the treatment, whether or not related to the drug, will be recorded. The safety assessment should include all undesirable changes of medical findings (including a clinical test finding) noted during medical visits as needed according to local practice guidelines and all AEs associated with surveillance drug administration.

    Adverse event will be collected from baseline(Day1) to 3 days after 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks))

Secondary Outcomes (3)

  • Changes in HbA1c before and after administration of Forxiga

    Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance

  • Changes in FPG before and after administration of Forxiga

    Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance

  • Changes in 2-hr PPG before and after administration of Forxiga

    Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance

Study Arms (1)

T2DM patients treated with Forxiga

Korean patients who are at least 18 years old, diagnosed with type2 diabetes and treated with Forxiga according to the approved lable

Eligibility Criteria

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

Adult patients with type 2 diabetes mellitus who are initiating Forxiga

You may qualify if:

  • Patients aged 18 years and older
  • Patients with T2DM eligible for treatment with Forxiga as indicated in the locally approved prescribing information
  • Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

  • Patients treated with Forxiga outside of the locally approved label in Korea
  • Patients with contraindications for the use of Forxiga (as described in the Korean product label)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Bucheon-si, South Korea

Location

Research Site

Busan, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Jeonju, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Wŏnju, South Korea

Location

Related Publications (1)

  • Han E, Kim A, Lee SJ, Kim JY, Kim JH, Lee WJ, Lee BW. Characteristics of Dapagliflozin Responders: A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea. Diabetes Ther. 2018 Aug;9(4):1689-1701. doi: 10.1007/s13300-018-0470-9. Epub 2018 Jul 11.

    PMID: 29998370DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • A Ri Kim

    AstraZeneca Korea - Medical Affairs

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

September 23, 2014

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

KR(6)