Januvia Re-examination Study (MK-0431-181 AM3)

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 22, 2013
Last verified: July 2013
  Purpose

The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean patients, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean patients.


Condition Intervention
Diabetes Mellitus Non-insulin-dependent
Drug: Sitagliptin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Use to Assess the Safety and Efficacy Profile of Januvia

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: 3459
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
1
Korean patients with non-insulin-dependent Diabetes Mellitus being treated with Januvia
Drug: Sitagliptin
Sitagliptin in general use
Other Name: Januvia

  Eligibility

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

Korean patients with non-insulin-dependent 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 and equal to 24 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062048

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor 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 22, 2013
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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014