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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Sitagliptin/metformin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin | Drug: Sitagliptin/metformin<br>* Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.<br>* Other names: JANUMET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Any Adverse Experience | 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. | Up to 26 weeks | 
| Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at 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. | Baseline and Week 12 | 
| Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at 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. | Baseline and Week 12 | 
| Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at 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. | Baseline and Week 12 | 
| Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse 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. | At Week 12 | 
| Change From Baseline to Treatment in HbA1c at 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. | Baseline and Week 24 | 
| Change From Baseline to Treatment in FPG at 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. | Baseline and Week 24 | 
| Change From Baseline in 2hr-PPG at 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. | Baseline and Week 24 | 
| Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse 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. | At Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Non-Insulin-Dependent