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NCT01223456 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

— ONGLYZA PMS  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01223456
Other study ID # NIS-CPH-DUM-2010/1
Secondary ID
Status Terminated
Phase N/A
First received October 14, 2010
Last updated October 7, 2013
Start date October 2010
Est. completion date December 2012

Study information
Verified date October 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 542
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Philippines Research Site Batangas City Batangas
Philippines Research Site Cebu City Cebu
Philippines Research Site Davao City Davao
Philippines Research Site Iloilo City Iloilo
Philippines Research Site Las Pinas City Manila
Philippines Research Site Mabalacat Pampanga
Philippines Research Site Makati Manila
Philippines Research Site Manila
Philippines Research Site Pasig Manila
Philippines Research Site Quezon City Manila

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events observed during the treatment duration Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up Yes
Primary Clinical Response determined by cure rate Up to three (3) months after initiation of treatment No
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