Januvia Re-examination Study (MK-0431-181)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062048
• Other study ID #: 0431-181
• Secondary ID: 2010_003
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: February 3, 2016
• Start date: October 2008
• Est. completion date: July 2013

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3483
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label
• Sulfonylurea
Sulfonylurea administered in general use according to the local label

Biological:
• Insulin
Insulin administered in general use according to the local label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with any adverse experience		up to 14 days following cessation of treatment	Yes
Primary	Mean change in Hemoglobin A1c (HbA1c)		12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment	No
Primary	Mean change in fasting plasma glucose (FPG)		12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment	No
Primary	Mean change in 2hr-postprandial glucose (PPG)		12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment	No