NCT01575483

Brief Summary

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,433

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4.5 years

First QC Date

April 10, 2012

Last Update Submit

August 7, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Adverse events occurrence

    30 days after last dose of study drug

Secondary Outcomes (2)

  • Number of Adverse Events and Serious Adverse Events

    30 days after last dose of study drug

  • Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data

    Baseline (Week 0), 12 weeks and 24 weeks of registration

Study Arms (1)

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®)

Interventions

No Intervention (subjects were previously treated with Onglyza®)DRUG

No Intervention

Also known as: saxagliptin
Patients with T2DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of type 2 diabetes mellitus initiating Onglyza® treatment within the approved indications will be enrolled

You may qualify if:

  • Female and male patients who are at least 18 years of age
  • Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea

You may not qualify if:

  • Indication which is not approved for Onglyza® in Korea
  • Patients with contraindication for the use of Onglyza® (as clarified in Korean label)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    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

April 10, 2012

First Posted

April 11, 2012

Study Start

March 1, 2012

Primary Completion

September 7, 2016

Study Completion

September 7, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

KR(1)