Korean Post-marketing Surveillance for Onglyza®
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01575483
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3433
Inclusion Criteria
- Female and male patients who are at least 18 years of age
- Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea
Exclusion Criteria
- Indication which is not approved for Onglyza® in Korea
- Patients with contraindication for the use of Onglyza® (as clarified in Korean label)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with T2DM No Intervention (subjects were previously treated with Onglyza®) Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled
- Primary Outcome Measures
Name Time Method Adverse events occurrence 30 days after last dose of study drug
- Secondary Outcome Measures
Name Time Method Number of Adverse Events and Serious Adverse Events 30 days after last dose of study drug Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data Baseline (Week 0), 12 weeks and 24 weeks of registration
Trial Locations
- Locations (1)
Research Site
🇰🇷Seoul, Korea, Republic of
Research Site🇰🇷Seoul, Korea, Republic of