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| Name | Class |
|---|---|
| Amylin Pharmaceuticals, LLC. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
| International Diabetes Center at Park Nicollet | OTHER |
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The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily. |
|
| Metformin | Active Comparator | Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | exenatide 10 mcg twice daily |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reactive Hyperemic Index Over the 3-month Treatment Period | Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health. | Change from baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron S. Kelly, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Diabetes Center at Park Nicollet | Saint Louis Park | Minnesota | 55416 | United States | ||
| St. Paul Heart Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22681705 | Derived | Kelly AS, Bergenstal RM, Gonzalez-Campoy JM, Katz H, Bank AJ. Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial. Cardiovasc Diabetol. 2012 Jun 8;11:64. doi: 10.1186/1475-2840-11-64. |
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Patients were recruited from medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide | Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months. |
| FG001 | Metformin | Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide | Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months. |
| BG001 | Metformin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Hyperemic Index Over the 3-month Treatment Period | Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health. | All completers were included in the analysis | Posted | Mean | Standard Deviation | ratio | Change from baseline to 3 months |
|
3-months
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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 | Exenatide | Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months. |
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unblinded study design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron S. Kelly, Ph.D. | University of Minnesota | 612-626-3492 | kelly105@umn.edu |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Drug |
metformin 500 twice daily |
|
| Saint Paul |
| Minnesota |
| 55102 |
| United States |
Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months. |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Metformin | Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months. | 0 | 25 | 0 | 25 |
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| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |