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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: Sulfonylurea; Biological: Insulin

• Registration Number: NCT01062048
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3483

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Sulfonylurea	Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
All participants	Insulin	Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
All participants	Sitagliptin	Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)

Primary Outcome Measures

Name	Time	Method
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