NCT01223456

Brief Summary

This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
542

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
terminated

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

October 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

October 14, 2010

Last Update Submit

October 7, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Saxagliptintype 2 diabetesclinical practice

Outcome Measures

Primary Outcomes (2)

  • Adverse events observed during the treatment duration

    Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up

  • Clinical Response determined by cure rate

    Up to three (3) months after initiation of treatment

Eligibility Criteria

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

several private and government hospitals

You may qualify if:

  • Diagnosis of Type 2 Diabetes Mellitus
  • Prescribed Saxagliptin by patient's attending physician

You may not qualify if:

  • Known allergic or serious adverse reaction to Saxagliptin
  • Pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Batangas, Batangas, Philippines

Location

Research Site

Cebu City, Cebu, Philippines

Location

Research Site

Davao City, Davao Region, Philippines

Location

Research Site

Iloilo City, Iloilo, Philippines

Location

Research Site

Las Piñas, Manila, Philippines

Location

Research Site

Makati, Manila, Philippines

Location

Research Site

Manila, Manila, Philippines

Location

Research Site

Pasig, Manila, Philippines

Location

Research Site

Quezon City, Manila, Philippines

Location

Research Site

Mabalacat, Pampanga, Philippines

Location

Research Site

Manila, Philippines

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Milagros Tan, MD

    AstraZeneca Philippines

    STUDY DIRECTOR

  • Emmanuel Arca, MD

    AstraZeneca Philippines

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 19, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

PH(11)