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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.
Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Januvia 100mg | Active Comparator | The first group will be started on 100 mg sitagliptin daily for 12 weeks |
|
| placebo | Placebo Comparator | will be placed on a placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Januvia (Sitagliptin) 100 mg | Drug | The first group will be started on 100 mg sitagliptin daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidative Stress From Baseline to 12 Weeks | To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients Outcome measures given are calculated from the baseline - 12 weeks. | value at 12 weeks minus value at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD | Kaleida Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 115 Flint Road | Buffalo | New York | 14221 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Januvia 100mg | The first group will be started on 100 mg sitagliptin daily for 12 weeks Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks |
| FG001 | Placebo | will be placed on a placebo for 12 weeks. Placebo: will be placed on a placebo for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Januvia 100mg | The first group will be started on 100 mg sitagliptin daily for 12 weeks Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks |
| BG001 | Placebo |
| 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 in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients | Posted | Mean | Standard Error | Percent change | 12 weeks |
|
12 weeks
There were no participants at risk of an adverse event.
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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 | Januvia 100mg | The first group will be started on 100 mg sitagliptin daily for 12 weeks Januvia (Sitagliptin) 100 mg: The first group will be started on 100 mg sitagliptin daily for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona | State University of NY at Buffalo | 7165351850 | dandona@buffalo.edu |
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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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | will be placed on a placebo for 12 weeks. |
|
will be placed on a placebo for 12 weeks.
Placebo: will be placed on a placebo for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c | Mean | Standard Deviation | percentage |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Oxidative Stress From Baseline to 12 Weeks | To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients Outcome measures given are calculated from the baseline - 12 weeks. | Posted | Mean | Standard Error | mM | value at 12 weeks minus value at baseline |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | will be placed on a placebo for 12 weeks. Placebo: will be placed on a placebo for 12 weeks. | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |