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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01223456
First received: October 14, 2010
Last updated: October 7, 2013
Last verified: October 2013

October 14, 2010
October 7, 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 ] [ Designated as safety issue: Yes ]
  • Clinical Response determined by cure rate [ Time Frame: Up to three (3) months after initiation of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01223456 on ClinicalTrials.gov Archive Site
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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
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*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01223456
NIS-CPH-DUM-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Milagros Tan, MD AstraZeneca Philippines
Study Chair: Emmanuel Arca, MD AstraZeneca Philippines
AstraZeneca
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP