Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Exenatide

• Registration Number: NCT02090673
• Lead Sponsor: AstraZeneca

Brief Summary

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1711

Inclusion Criteria

• Male or female at least 18 years of age
• Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
• Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion Criteria

• Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
• Are pregnant or have intentions of becoming pregnant within the duration of the study
• Contraindications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1:Type 2 diabetic patients treated with Exenatide therapy	Exenatide	Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label

Primary Outcome Measures

Name	Time	Method
The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus	At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in Hemoglobin A1c (HbA1c)	Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Body weight	Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Fasting plasma glucose	Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in subjective measures include improvement of main indication	Baseline (Day 1) and 12 or 24 weeks ± 4 weeks

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of