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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_006 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin/metformin | Drug | Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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In this post-marketing surveillance study of sitagliptin/metformin (JANUMET®), participants in South Korea treated for >= 24 weeks were evaluated for long-term safety and efficacy. During the re-examination study period (December 4, 2005 to September 20, 2013), case report forms (CRFs) were collected from 4,065 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Included in the Safety Evaluation | Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were only reported for the Safety Population (4033) who qualified for the study and not for the 4065 participants from whom CRFs were collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Included in the Safety Evaluation | Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who were included in the safety evaluation | Posted | Number | Percentage of participants | Up to 26 weeks |
|
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Up to 26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Included in the Safety Evaluation | Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-888-577-8839 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | All participants with a pre-treatment and a 12-week post-treatment HbA1c value. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Baseline and Week 12 |
|
|
|
| Primary | 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. | Participants with a pre-treatment and a 12-week post-treatment measurement of FPG. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | 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. | Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | 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. | Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. | Posted | Number | Percentage of participants | At Week 12 |
|
|
|
| Primary | 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. | All participants with a pre-treatment and a 24-week post-treatment HbA1c value. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Baseline and Week 24 |
|
|
|
| Primary | 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. | Participants with a pre-treatment and a 24-week post-treatment measurement of FPG. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | 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. | Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | 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. | Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. | Posted | Number | Percentage of participants | At Week 24 |
|
|
|
| 17 |
| 4,033 |
| 0 |
| 4,033 |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 16.1 | Systematic Assessment |
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| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| CHRONIC HEPATITIS C | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| TENSION HEADACHE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
In regard to surveillance result, any publication should be agreed by sponsor in advance.
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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