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Completion of MK-0431A-235 was rendered unnecessary, as the local oversight authority accepted in its stead the results of another study [MK-0431-234].
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The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with sitagliptin phosphate/metformin HCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin Phosphate/Metformin HCl (JANUMET®) | Drug | Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event | Up to approximately 28 months | |
| Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl | Up to approximately 28 months | |
| Number of Participants With Concomitant Conditions | Up to approximately 28 months | |
| Number of Participants Taking Concomitant Medications | Up to approximately 28 months |
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Inclusion Criteria:
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Participants with type 2 diabetes mellitus who are treated with sitagliptin phosphate/metformin HCl as per the standard of care in a physician's practice
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This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate/metformin HCL (JANUMET®) in clinical practices in the Philippines from January 2009 to May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin Phosphate/Metformin HCl | Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin Phosphate/Metformin HCl | Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice. |
| 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 | Number of Participants With an Adverse Event | Posted | Number | participants | Up to approximately 28 months |
|
|
Up to approximately 28 months
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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 | Sitagliptin Phosphate/Metformin HCl | Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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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 |
| 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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| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
| Primary | Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl | Posted | Mean | Standard Deviation | years | Up to approximately 28 months |
|
|
|
| Primary | Number of Participants With Concomitant Conditions | Posted | Number | participants | Up to approximately 28 months |
|
|
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| Primary | Number of Participants Taking Concomitant Medications | Posted | Number | participants | Up to approximately 28 months |
|
|
|
| 0 |
| 143 |
| 0 |
| 143 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |