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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_525 |
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After 24 weeks of treatment evaluate the efficacy and security.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sitagliptin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 24 | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values. | Baseline and 24 Weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Treatment naïve patients (30 to 78 years of age) with inadequate glycemic control on diet/exercise were assigned to treatment with sitagliptin alone (A1C 6.5 to <8%), sitagliptin + metformin as initial combination therapy (A1C 8-12%), or standard care.
Single site study with patients recruited in Principal Investigator's private practice, Mexico City.
First Patient In: 14Feb2007. Last Patient's Last Visit: 11Jul2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg q.d. (Once Daily) | |
| FG001 | Sitagliptin 100 mg q.d. (Once Daily) and Metformin | |
| FG002 | Standard Care Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg q.d. (Once Daily) | |
| BG001 | Sitagliptin 100 mg q.d. (Once Daily) and Metformin | |
| BG002 | Standard Care Regimen | Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Glycosylated Hemoglobin A1C (A1C) | Mean | Standard Deviation | Percent |
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| Time Since Diagnosis of Diabetes | Mean | Standard Deviation | Years |
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| 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 A1C at Week 24 | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values. | Posted | Mean | 95% Confidence Interval | Percent Difference | Baseline and 24 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 | Sitagliptin 100 mg q.d. (Once Daily) | 0 | 12 | 1 | 12 | |||
| EG001 | Sitagliptin 100 mg q.d. (Once Daily) and Metformin | 0 | 16 | 0 | 16 | |||
| EG002 | Standard Care Regimen | Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group. | 0 | 1 | 0 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MEDRA 13.1 |
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Few participants were recruited into this single-site study as the investigator preferred the use of initial combination therapy.
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
| D011719 | Pyrazines |
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| Male |
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