Type 2 Diabetes Mellitus
Conditions
Brief summary
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Interventions
DRUGSitagliptin
Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label
DRUGSulfonylurea
Sulfonylurea administered in general use according to the local label
BIOLOGICALInsulin
Insulin administered in general use according to the local label
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes Mellitus * Treated With Januvia within local label for the first time
Exclusion criteria
* Contraindication to Januvia according to the local label * Treated with Januvia before contract and out of enrollment period Inclusion criteria for long-term surveillance * Treated with Januvia for more than or equal to 24 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with any adverse experience | up to 14 days following cessation of treatment |
| Mean change in Hemoglobin A1c (HbA1c) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment |
| Mean change in fasting plasma glucose (FPG) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment |
| Mean change in 2hr-postprandial glucose (PPG) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment |
Outcome results
None listed