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

This study is currently recruiting participants.
Verified November 2012 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01223456
First received: October 14, 2010
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  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:

Drug Information available for: Saxagliptin
U.S. FDA Resources

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 ]

Estimated Enrollment: 3000
Study Start Date: October 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223456

Contacts
Contact: AstraZeneca Philippines Patient Safety Unit Clinical Study Information + 63 2 777 8816 Philippines.SAEMailbox@astrazeneca.com

Locations
Philippines
Research Site Recruiting
Batangas City, Batangas, Philippines
Research Site Recruiting
Cebu City, Cebu, Philippines
Research Site Recruiting
Davao City, Davao, Philippines
Research Site Recruiting
Iloilo City, Iloilo, Philippines
Research Site Recruiting
Las Pinas City, Manila, Philippines
Research Site Recruiting
Makati, Manila, Philippines
Research Site Recruiting
Pasig, Manila, Philippines
Research Site Recruiting
Quezon City, Manila, Philippines
Research Site Recruiting
Mabalacat, Pampanga, Philippines
Research Site Recruiting
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: November 5, 2012
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
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013