Korean Post-marketing Surveillance for Onglyza®

Study identifier:CV181-171

ClinicalTrials.gov identifier:NCT01575483

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Korean Post-marketing Surveillance for Onglyza®

Medical condition

Diabetes Mellitus, Type 2

Phase

Healthy volunteers

Study drug

No Intervention (subjects were previously treated with Onglyza®)

Sex

All

Actual Enrollment

3433

Study type

Observational

Age

18 Years +

Date

Study Start Date: 01 Mar 2012

Primary Completion Date: 07 Sept 2016

Study Completion Date: 07 Sept 2016

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Aug 2017 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Seoul, Republic of Korea

Arms	Assigned Interventions
Patients with T2DM Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled	Drug: No Intervention (subjects were previously treated with Onglyza®) No Intervention Other Name: saxagliptin

Documents available

FDA Safety Alerts and Recalls
Download
CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

Korean Post-marketing Surveillance for Onglyza®

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Documents available

FDA Safety Alerts and Recalls

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator