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Study funding was for 1 year to a fellow who graduated in early stages of enrollment. While 6 patients were enrolled, many patients didn't finish the study and therefore little data was collected and no results will be entered.
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The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood glucose concentrations) and indices of oxidation stress in the plasma of these subjects.
The hypothesis is that Sitagliptin will improve overall blood glucose, fasting blood glucose, and glycemic excursions in patients with Type I Diabetes. In addition, sitagliptin will likely suppress indices of oxidative stress in patients. The study will investigate proposed mechanisms of improved glucose concentrations, including enhanced effect of endogenous GLP-1 and suppression of glucagon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | sitagliptin 100mg by mouth once a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in mean glucose concentrations | The primary endpoint of the study is to detect the change from baseline in mean glucose concentrations as measured by both HbA1c, and mean glucose over the three days of continuous glucose monitoring. | baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic changes | Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia. | baseline and 3 months |
| Post meal hyperglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD | Kaleida Health and University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 115 Flint Road | Williamsville | New York | 14221 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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 | Take one by mouth daily for 12 weeks |
|
Post meal hyperglycemia will be measured as area under the curve (AUC).
| baseline and 3 months |
| Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge. | baseline and 3 months |
| Changes in NF kappa B in the fasting state. | baseline and 3 months |
| Change in NFkappaB following meal challenge. | baseline and 3 Months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011719 |
| Pyrazines |