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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Sitagliptin; Drug: Sulfonylurea; Biological: Insulin

• Study Type: Observational
• Enrollment (Actual): 3483

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Korean participants with Type 2 Diabetes Mellitus being treated with Januvia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; 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)	Drug: Sitagliptin; Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label; Other Names: Januvia; Drug: Sulfonylurea; Sulfonylurea administered in general use according to the local label; Biological: Insulin; Insulin administered in general use according to the local label

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-181; 2010_003 (Other Identifier: Merck Registration Number)