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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01062048
First received: February 2, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Sitagliptin
Drug: Sulfonylurea
Biological: Insulin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants with any adverse experience [ Time Frame: up to 14 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Mean change in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment ] [ Designated as safety issue: No ]
  • Mean change in fasting plasma glucose (FPG) [ Time Frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment ] [ Designated as safety issue: No ]
  • Mean change in 2hr-postprandial glucose (PPG) [ Time Frame: 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment ] [ Designated as safety issue: No ]

Enrollment: 3483
Study Start Date: October 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean participants with Type 2 Diabetes Mellitus being treated with Januvia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062048

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01062048     History of Changes
Other Study ID Numbers: 0431-181, 2010_003
Study First Received: February 2, 2010
Last Updated: July 18, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Diabetes Mellitus non-insulin-dependent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014