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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin/metformin

• Registration Number: NCT01065766
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-03-11
• Results First Submitted QC: 2014-03-11
• Results First Posted: 2014-04-17
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4065

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Sitagliptin/metformin	Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Any Adverse Experience	Up to 26 weeks	An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12	Baseline and Week 12	Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12	Baseline and Week 12	Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12	At Week 12	Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Change From Baseline to Treatment in HbA1c at Week 24	Baseline and Week 24	HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
Change From Baseline to Treatment in FPG at Week 24	Baseline and Week 24	Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
Change From Baseline in 2hr-PPG at Week 24	Baseline and Week 24	Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24	At Week 24	Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12	Baseline and Week 12	HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.