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Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Sitagliptin/metformin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Clinical Details

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice

Study design: Time Perspective: Prospective

Primary outcome:

Percentage of Participants With Any Adverse Experience

Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12

Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12

Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12

Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12

Change From Baseline to Treatment in HbA1c at Week 24

Change From Baseline to Treatment in FPG at Week 24

Change From Baseline in 2hr-PPG at Week 24

Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has type 2 diabetes mellitus

- Is treated with sitagliptin/metformin within local label for the first time

Exclusion Criteria:

- Has a contraindication to sitagliptin/metformin according to the local label

- Is treated with sitagliptin/metformin before contract and out of enrollment period

Locations and Contacts

Additional Information

Starting date: March 2009
Last updated: February 18, 2015

Page last updated: August 23, 2015

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