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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_526 |
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Business Reasons
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to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 | Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected. | Baseline and Week 18 |
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Inclusion Criteria:
Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Patients between 18 and 75 years old with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, who had not taken medication for at least 2 months or using a single drug for diabetes mellitus were enrolled in the study. Insulin-dependent patients were excluded from the study.
Recruitment process occurred in the Hospital Regional de Taguatinga between November, 26 2008 and May, 27 2009.
First Patient in: 26-Nov-2008; Last patient in: 27- May- 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks |
| 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 (Hemoglobin A1c) at Week 18 | Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected. | The study was terminated early and no data were analyzed for this outcome. | Posted | Baseline and Week 18 |
|
|
The planned 18-week study was terminated early due to reconsideration of the study design.
None of the 10 patients progressed beyond the second study visit, no laboratory tests were performed, and adverse experience data were not collected.
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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 100 mg | Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks |
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The planned 18-week study was terminated early due to reconsideration of the study design. None of the 10 patients progressed beyond the second study visit, no laboratory tests were performed, and adverse experience data were not collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |