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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-103 | |||
| 2009_527 |
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Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Sitagliptin 100 mg/day - tablet for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent | Baseline and Week 12 |
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Inclusion Criteria:
Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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First patient in: 11-MAR-2008
Last patient out: 30-OCT-2009
Total number of sites: 110
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100mg |
| 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 | Change From Baseline in HbA1c at Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent | Includes all patients who received at least one dose of study medication and have a Week 24 measure. | Posted | Mean | Standard Deviation | Percent | Baseline and Week 24 |
|
|
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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 100mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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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 |
| ID | Term |
|---|---|
| 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lost to Follow-up |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Missing |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent |
|
| Weight | Mean | Standard Deviation | Kilograms |
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| Fasting plasma glucose | Mean | Standard Deviation | mmol/L |
|
|
|
| Secondary | Change From Baseline in HbA1c at Week 12 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent | Includes all patients who received at least one dose of study medication and have a Week 12 measure. | Posted | Mean | Standard Deviation | Percent | Baseline and Week 12 |
|
|
|
| 17 |
| 608 |
| 0 |
| 608 |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Meningoencephalitis herpetic | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D011719 |
| Pyrazines |