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

Terminated

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT01223456
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-07
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 542

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events observed during the treatment duration	Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up
Clinical Response determined by cure rate	Up to three (3) months after initiation of treatment

Trial Locations

Locations (1)

Research Site; 🇵🇭 Manila, Philippines