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
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Enrollment: 542
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

several private and government hospitals

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223456

Locations
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
Makati, Manila, Philippines
Research Site
Pasig, Manila, Philippines
Research Site
Quezon City, Manila, Philippines
Research Site
Mabalacat, Pampanga, Philippines
Research Site
Manila, Philippines
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Milagros Tan, MD AstraZeneca Philippines
Study Chair: Emmanuel Arca, MD AstraZeneca Philippines
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01223456     History of Changes
Other Study ID Numbers: NIS-CPH-DUM-2010/1
Study First Received: October 14, 2010
Last Updated: October 7, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by AstraZeneca:
Saxagliptin
type 2 diabetes
clinical practice

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 18, 2014