Diabetes Mellitus Type 2
Conditions
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.
Interventions
DRUGExenatide
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed