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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090673
• Other study ID #: MB001-078
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: August 19, 2015
• Start date: February 2009
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1711
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Exenatide

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change from baseline to endpoint in Hemoglobin A1c (HbA1c)		Baseline (Day 1) and 12 or 24 weeks ± 4 weeks	No
Secondary	Change from baseline to endpoint in Body weight		Baseline (Day 1) and 12 or 24 weeks ± 4 weeks	No
Secondary	Change from baseline to endpoint in Fasting plasma glucose		Baseline (Day 1) and 12 or 24 weeks ± 4 weeks	No
Secondary	Change from baseline to endpoint in subjective measures include improvement of main indication		Baseline (Day 1) and 12 or 24 weeks ± 4 weeks	No

External Links

•   BMS Clinical Trials Disclosure
•   CSR_Synopsis_MB001-078.pdf
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form