Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use

A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01223456

Acronym

ONGLYZA PMS

Enrollment

542

Registered

2010-10-19

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Saxagliptin, type 2 diabetes, clinical practice

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Philippines

Outcome results