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

This study has been terminated.
(Inability to recruit adequate number of patients within the specified time period.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223456
First Posted: October 19, 2010
Last Update Posted: October 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
October 14, 2010
October 19, 2010
October 8, 2013
October 2010
December 2012   (Final data collection date for primary outcome measure)
  • Adverse events observed during the treatment duration [ Time Frame: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up ]
  • Clinical Response determined by cure rate [ Time Frame: Up to three (3) months after initiation of treatment ]
Same as current
Complete list of historical versions of study NCT01223456 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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.
Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample
several private and government hospitals
Type 2 Diabetes Mellitus
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
542
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT01223456
NIS-CPH-DUM-2010/1
No
Not Provided
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AstraZeneca
AstraZeneca
Not Provided
Study Director: Milagros Tan, MD AstraZeneca Philippines
Study Chair: Emmanuel Arca, MD AstraZeneca Philippines
AstraZeneca
October 2013