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Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITCA 650 60 mcg/day | Experimental | ITCA 650 is exenatide in DUROS |
|
| ITCA placebo | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITCA 650 | Drug | ITCA 650 |
| |
| ITCA placebo |
| Measure | Description | Time Frame |
|---|---|---|
| time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina), | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Chandler | Arizona | 85224 | United States | ||
| Intarcia Therapeutics, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34873344 | Derived | Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS. Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Nat Med. 2022 Jan;28(1):89-95. doi: 10.1038/s41591-021-01584-3. Epub 2021 Dec 6. | |
| 29693361 | Derived | Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155. |
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| Other |
ITCA placebo |
|
| Hayward |
| California |
| 94545 |
| United States |
| Study Site | Long Beach | California | 90806 | United States |
| Study Site | Port Hueneme | California | 93041 | United States |
| Study SIte | San Diego | California | 92114 | United States |
| Study Site | Bradenton | Florida | 34208 | United States |
| Study Site | New Port Richey | Florida | 34652 | United States |
| Study Site | Palm Harbor | Florida | 34684 | United States |
| Study Site | Chicago | Illinois | 60634 | United States |
| Study Site | Avon | Indiana | 46123 | United States |
| Study Site | Evansville | Indiana | 47714 | United States |
| Study Site | Franklin | Indiana | 46131 | United States |
| Study Site | Greenfield | Indiana | 46140 | United States |
| Study Site | Muncie | Indiana | 47304 | United States |
| Study Site | Newton | Kansas | 67114 | United States |
| Study Site | Wichita | Kansas | 67205 | United States |
| Study Site | Wichita | Kansas | 67207 | United States |
| Study Site | Metaire | Louisiana | 70006 | United States |
| Study Site | Rochester | Michigan | 48307 | United States |
| Study Site | St Louis | Missouri | 63141 | United States |
| Study Site | Billings | Montana | 59101 | United States |
| Study Site | Las Vegas | Nevada | 89128 | United States |
| Las Vegas | Nevada | 89148 | United States |
| Study Site | Winston-Salem | North Carolina | 27103 | United States |
| Study Site | Cincinnati | Ohio | 45236 | United States |
| Study Site | Columbus | Ohio | 43213 | United States |
| Study Site | Franklin | Ohio | 45005 | United States |
| Study Site | Pittsburgh | Pennsylvania | 15236 | United States |
| Study Site | Uniontown | Pennsylvania | 15401 | United States |
| Study Site | Greer | South Carolina | 29651 | United States |
| Study Site | Austin | Texas | 78745 | United States |
| Dallas | Texas | 75230 | United States |
| Study Site | Dallas | Texas | 75231 | United States |
| Study Site | San Antonio | Texas | 78229 | United States |
| Plovdiv | 4002 | Bulgaria |
| Hvidovre | 2650 | Denmark |
| Oulu | 90100 | Finland |
| Bad Lauterberg im Harz | Lower Saxony | 37431 | Germany |
| Sopot | 81-717 | Poland |
| Martin | 03659 | Slovakia |
| Johannesburg | Gauteng | 2193 | South Africa |
| Istanbul | 34098 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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