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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_003 | Other Identifier | Merck Registration Number |
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The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with any adverse experience | up to 14 days following cessation of treatment | |
| Mean change in Hemoglobin A1c (HbA1c) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment | |
| Mean change in fasting plasma glucose (FPG) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment | |
| Mean change in 2hr-postprandial glucose (PPG) | 12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for long-term surveillance
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Korean participants with Type 2 Diabetes Mellitus being treated with Januvia
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D013453 | Sulfonylurea Compounds |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sulfonylurea | Drug | Sulfonylurea administered in general use according to the local label |
|
| Insulin | Biological | Insulin administered in general use according to the local label |
|
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |