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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

February 2, 2010
July 18, 2014
October 2008
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment [ Time Frame: up to 14 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Mean change from baseline to treatment in HbA1c, FPG and 2hr-PPG and overall efficacy evaluation by investigator (improved, stable or worse) [ Time Frame: At 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01062048 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Probability Sample

Korean participants with Type 2 Diabetes Mellitus being treated with Januvia

Type 2 Diabetes Mellitus
  • 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
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)
Interventions:
  • Drug: Sitagliptin
  • Drug: Sulfonylurea
  • Biological: Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3483
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01062048
0431-181, 2010_003
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP