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

February 2, 2010
July 22, 2013
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 AM3)
Re-examination Study for General Use to Assess the Safety and Efficacy Profile of Januvia

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.

Not Provided
Observational
Time Perspective: Prospective
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Probability Sample

Korean patients with non-insulin-dependent Diabetes Mellitus being treated with Januvia

Diabetes Mellitus Non-insulin-dependent
Drug: Sitagliptin
Sitagliptin in general use
Other Name: Januvia
1
Korean patients with non-insulin-dependent Diabetes Mellitus being treated with Januvia
Intervention: Drug: Sitagliptin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3459
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 and equal to 24 weeks
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01062048
0431-181, 2010_003
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2013

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